Dermagic Journal of MEDermatology

 

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January 2004 The bextra side effects

February 2004 The dark side of the vaccines and thimerosal in the Autism

March 2004 The nimesulide, fallen angel.

April 2004 The Morphea, New therapeutic alternatives.

May 2004 The Imiquimod (Aldara), an Update.

June 2004 Zyban the day after tomorrow.

July 2004 Nimesulide, parecoxib, valdecoxib, galantamine, isotretionoin, capecitabine.

August 2004   Voriconazole, Isotretinoin.

September 2004  The fall of the vioxx.

 

 

                               

                                           OCTUBRE 2.004-05

                                           OCTOBER 2.004-05

  LAS DOCE DEL PATIBULO- THE DIRTY DOZEN

 

 
ESPAÑOL

Hola amigos de la red, EL MEDermagic JOURNAL en esta edicion de OCTUBRE 2.004 les presenta en este tema super caliente LAS 12 MOLECULAS DEL PATIBULO, aquellas drogas que fueron inventadas para proporcionar salud a la poblacion y que por una u otra razon, salieron del mercado. Algunas de ellas regresaron, otras todavia se venden, Conozca a traves de esta HISTORIA el IMPRESIONANTE mundo de algunas de estas moleculas.

Si bien es una verdad que nuestros QUERIDOS LABORATORIOS TRABAJAN POR NUESTRA SALUD,,, tambien debemos reconocer que trabajan POR LOS miles de billones de dolares se ganan vendiendo medicinas....

Quiza algunas de ellas sigan en el mercado por mucho tiempo, lo que no significa que sean monedas de ORO, si usted VA a utilizarlas PIENSELO BIEN y conozca bien la molecula.

Suludos

Dr Jose Lapenta

ENGLISH

Hello friends of the net, THE DERMAGIC in this occasion presents you in this OCTOBER 2.004 super hot topic THE DOZEN DIRTY MOLECULES, those drugs that were invented to provide health to the population and that for an or another reason, they left the market. Some of them returned, other they are still sold, Know through this HISTORY the IMPRESSIVE world of some of these molecules.

Although it is a true that our DEAR LABORATORIES WORK FOR OUR HEALTH, also should recognize that they also work FOR THE thousands of trillion dollars they are won selling medicines.

Some of them maybe continue in the market for a lot of time, what doesn't mean that they are coins of GOLD, if you plans to use them you THINK IT WELL and know well the molecule.

Greetings

Dr Jose Lapenta

BROWN = Withdrawn and re-marketed.
RED: Withdrawal from the Market.
BLUE: Still in the Market, with warnings by the FDA

 

 1.) THE THALIDOMIDE./LA TALIDOMIDA.(CELGENE Corps).

2.) THE POSICOR (MIFEBRADIL)/ EL POSICOR (MIFEBRADIL) Lab ROCHE).

3.) THE BAYCOL, LIPOBAY /EL LIPOBAY, (CERIVASTATIN) (Lab BAYER).

4.) THE TROVAN/ EL TROVAN (TROVAFLOXACIN), (Lab PFIZER).

5.) THE HISMANAL (ASTEMIZOLE), (Lab JANSSEN-CILAG Pharm).

6.) THE PROPULSID/ PREPULSID (CISAPRIDE), (Lab JANSSEN-CILAG P).

7.) THE VIOXX (ROFECOXIB), (Lab MERCK S. and D.)

8.) THE AULIN (NIMESULIDE), (Lab Shering-Plough and others).

9.) THE YASMIN (ANTICONCEPTIVE), (Lab. SCHERING Germany).

10.) THE CELEBREX (CELECOXIB), (Lab. PFIZER).

11.) THE ISOTRETINOIN (ACCUTANE-ROACCUTANE), (Lab. ROCHE).

12.) THE BEXTRA (VALDECOXIB), (Lab. PFIZER).

 

 

1.) THE THALIDOMIDE/ LA TALIDOMIDA, (CELGENE Corps).

The THALIDOMIDE, a medication that in the years 50 caused a generation of children with malformations. This product, fallen in misfortune from that time, with the time he was been demonstrating their utility in varied dermatologic and NON dermatologic pathologies and nowadays, the 16 of July 1.998 were approved AGAIN by the American FDA, for the treatment of the leprous reaction.  


La TALIDOMIDA, un medicamento que en los años 50 causó una generación de niños con malformaciones. Este producto, caído en desgracia desde esa epoca, con el tiempo se le fue demostrando su utilidad en variadas patologías dermatológicas y no dermatológicas, y hoy dia, el 16 de Julio de 1.998 fue aprobado NUEVAMENTE por la FDA Americana, para el tratamiento de la reacción leprosa.  

===========================================
FDA Clears Thalidomide For Leprosy
===========================================

WARREN, NJ -- July 16, 1998 - The United States Food and Drug
Administration has granted marketing clearance to Celgene Corp.'s
Thalomid(TM) (thalidomide) for the treatment of erythema nodosum leprosum
(ENL), a severe and debilitating condition associated with leprosy.

Celgene licensed rights to thalidomide from The Rockefeller University in 1992
and began developing the drug for a range of potential indications. These
include AIDS related, dermatological and cancer related conditions.

In order to support the safe and appropriate use of the drug, due to concern
about the teratogenic potential of thalidomide in humans when the drug is take
during pregnancy, Celgene has developed a unique and comprehensive patient,
physician and pharmacist education and distribution system to be called the
System for Thalidomide Education and Prescribing Safety (STEPS).

Major Components of the STEPS Program include:
-- Physicians prescribing Thalomid and pharmacists dispensing the drug will
register and receive educational materials explaining risks and pregnancy
prevention methods, as well as expected side effects of therapy.

-- All females who are candidates for Thalomid therapy will be required to
undergo pregnancy testing before starting treatment and periodically thereafter.

-- Women will also be required to use effective birth control while taking the
drug.

-- Men using the drug will be required to use condoms when having sexual
relations with women.

-- All candidates for Thalomid therapy will be provided with counselling by the
physician and comprehensive multicultural and multilingual educational material
clearly explaining the risks of use. 

-- Patients will be required to sign an informed consent form after an
explanation of the risks of Thalomid use by the physician.

-- Before a prescription is filled, a copy of the informed consent form st be
presented at a pharmacy pre-registered to dispense Thalomid.
-- Persons using Thalomid will be required to participate in a patient survey
designed to determine compliance with the STEPS program and any situations
involving pregnancy.

-- Patients will be instructed never to share the drug with other persons,
including friends or relatives with the same symptoms for which Thalomid was
prescribed.

-- Thalomid packaging will contain clear and prominent warnings about the
risks associated with use. Prescriptions for Thalomid will be no more than a 28
day supply with no automatic renewals.



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2.) THE POSICOR (MIFEBRADIL)/ EL POSICOR (MIFEBRADIL), Lab. ROCHE).

In the year 1.997 the house ROCHE throws to the market the DRUG POSICOR (MIBEFRADIL), with blocking effect of the channels of the calcium for the handling of the hypertension and stable chronic angina. Postmarketing surveillance revealed a potential serious interaction between mibefradil and -blockers, digoxin, verapamil, and diltiazem, especially in elderly patients. The manufacturer (ROCHE) voluntarily withdrew mibefradil on June 8, 1998. Some PEOPLE died for the use of POSICOR. 

EL POSICOR (MIFEBRADIL)

En el año 1.997 la casa ROCHE lanzo al mercado la DROGA POSICOR (MIBEFRADIL), con efecto bloqueador de los canales del calcio para el manejo de la hipertension y angina cronica estable. Estudios de postmercadeo revelaron una potencial y seria interaccion entre esta droga y bloqueadores, digoxina, verapamil y diltiazem especialmente en personas de edad. El laboratorio ROCHE, VOLUNTARIAMENTE retiro del MERCADO EL MIBEFRADIL EL 8 de junio de 1.998. Unos cuantos murieron por el uso de POSICOR. 

=========================================
ROCHE LABORATORIES ANNOUNCES WITHDRAWAL
OF POSICOR FROM THE MARKET
=========================================
Source: The FDA.

Roche Laboratories of Nutley, NJ has announced that it is voluntarily withdrawing the heart drug, Posicor (mibefradil), from the market as a result of new information about potentially harmful interactions with other drugs. 
In many cases, drug interactions can be addressed by appropriate labeling changes and public education, but due to the complexity of the prescribing information needed in this case, and seriousness of side effects, FDA and Roche agreed that it would be difficult to administer Posicor safely. The following may be used to respond to inquiries. 

Posicor is a calcium-channel blocker, chemically unlike the other approved products in this class. Posicor was approved in June of last year, to be used in the treatment of patients with hypertension and chronic stable angina. 

Posicor reduces the activity of certain liver enzymes that are important in helping the body eliminate many other drugs. Inhibiting these enzymes can cause some of these other drugs to accumulate in the body to dangerous levels. 

When Posicor entered the market in August of 1997, its enzyme-inhibiting properties were described in the labeling. The labeling specifically listed three drugs (astemizole, cisapride, and terfenadine) that could be expected to accumulate to dangerous levels if Posicor was coadministered. 

In December, after learning of several cases in which patients suffered serious adverse reactions after taking Posicor with one or more of the other drugs, FDA strengthened the labeling of Posicor, and two more drugs (lovastatin and simvastatin) were added to the label's list of those that should never be coadministered with Posicor. FDA also issued a public warning about this problem and the company issued a Dear Doctor letter to physicians. 

From spontaneous reports and ongoing trials, FDA and Roche have continued to learn of adverse reactions related to coadministration of Posicor with several other drugs. At present, more than 25 drugs are known to be potentially dangerous if used with Posicor -- a number and diversity of drugs that cannot be practically addressed by standard label warnings. 

Since Posicor has not been shown to offer special benefits (such as treating patients who do not respond to other antihypertensive and anti-anginal drugs), the drug's problems are viewed as an unreasonable risk to consumers. 

Patients now taking Posicor should not simply discontinue treatment because stopping medications can be risky. Instead, patients should promptly consult with their physicians about appropriate alternative therapy. In addition, patients now taking Posicor should not add any new medication to their current treatment without consulting their physicians. 

Roche Laboratories is providing information in a "Dear Doctor" letter to physicians, pharmacists, nurse practitioners, and other health care professionals. Questions about the withdrawal of Posicor can be addressed to Roche's 24-hour hotline at 1-800-205-4611. 

The following is a list of drugs that depend on the same liver enzyme as Posicor (mibefradil). Use of them in combination with Posicor could be dangerous. 



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3.) THE BAYCOL, LIPOBAY (CERIVASTATIN), (Lab. BAYER).


That same year of 1.997 the house BAYER, throws to the WORLD MARKET THE DRUG BAYCOL, LIPOBAY (CERIVASTATIN) a member of the class of drugs that diminish the cholesterol commonly referred as "estatins ". For the year of 1.998 the first deads were reported by the use of this drug, because of a fatal RHABDOMYOLYSIS, mainly when it was used in combination with THE DRUG LOPID (GEMFIBROZIL) another drug used to diminish the cholesterol. 

REGRETTABLY the LABORATORY MADE ALL THE POSSIBLE one to COVER THIS RAW REALITY, and the people still dying because of this DRUG, until some months ago August 8, 2.001 and after the FDA had reported 31 deads in United States. The laboratory BAYER DECIDES to PUT AN END TO ITS MILLIONAIRE "MORTAL" DANCE taking OFF from the MARKET TO THE BAYCOL, LIPOBAY. Enough people DIED FOR THIS CAUSE. 

THE MONSTER BAYER FELT later WOUNDED and few days I BUY FOR 3 thousand million DOLLARS A PART OF THE LABORATORIO AVENTIS, that was its answer. 

EL LIPOBAY, BAYCOL (CERIVASTATINA) Laboratorio BAYER.
-----------------------------------------------------------------------------
Ese mismo año de 1.997 la CASA BAYER, UNO DE LOS "monstruos" en agroquimicos lanza al MERCADO MUNDIAL LA DROGA BAYCOL, LIPOBAY (CERIVASTATIN) un miembro de la clase  de drogas que disminuyen el colesterol comunmente referidas como "estatinas". Para el año de 1.998 se reportaron los primeros muertos por el uso de esta droga, a causa de una RABDOMIOLISIS fatal, sobre todo cuando era usada en combinacion con LA DROGA LOPID (GEMFIBROZIL) otra droga usada para bajar el colesterol. 

LAMENTABLEMENTE el LABORATORIO HIZO TODO LO POSIBLE POR "TAPAR" ESTA CRUDA REALIDAD, y la gente siguio muriendo a causa de esta DROGA, hasta que hace unos meses el 8 DE agosto de 2.001 y despues que la FDA habia reportado 31 muertos en Estados Unidos. el laboratorio BAYER DECIDE PONER FIN A SU DANZA "MORTAL" MILLONARIA sacando del MERCADO AL BAYCOL-LIPOBAY. Bastantes personas MURIERON POR ESTA CAUSA. 

EL MOSNTRUO BAYER SE SINTIO HERIDO y pocos dias despues COMPRO POR 3 mil millones de DOLARES UNA PARTE DEL LABORATORIO AVENTIS, esa fue su respuesta. 

=================================================
BAYER VOLUNTARILY WITHDRAWS BAYCOL- (LIPOBAY)
================================================
T01-34 Print Media: 301-827-6242 
August 8, 2001 Broadcast Media: 301-827-3434 
Consumer Inquiries: 888-INFO-FDA 

FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.

Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins. 

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.

Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal. 

Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund.

Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician. 

There are five other statins available in the U.S. that may be considered as alternatives to Baycol. They are: lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor).

For further information regarding the withdrawal of Baycol, patients and physicians can contact Bayer Customer Service 1-800-758-9794 or the FDA's Drug Information Office at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol Information" on FDA's Website.
BMJ. 2004 June 26; 328 (7455): 1537



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4.)  THE TROVAN/ EL TROVAN (TROVAFLOXACIN), ( Lab. PFIZER).
 

I
The trovafloxacina(TROVAN),antibiotic (fluoroquinolone) relatively new in the market, liberated by the FDA in February of 1.998, with big promotion and marketed by the famous laboratory PFIZER. 

One year later 140 CASES OF HEPATIC TOXICITY had already been reported, in some cases requiring of liver transplant, and death in some cases, with SINGLE THREE DAYS OF TREATMENT. THE FDA RECOMMENDED ITS EXIT OF THE MARKET IN JUNE 1.999.

Him but STRANGE of all this it is that TROVAN was THROWN TO THE MARKET with some PRELIMINARY studies where there were NEVER TOXIC EFFECTS IN THE LIVER. In Our country it was HARDLY retired LATER 2 MONTHS OF THEIR LAUNCHING.)

EL TROVAN (TROVAFLOXACINA): Laboratorio PFIZER.)
-------------------------------------------------------------------
La trovafloxacina(TROVAN), antibiotico (fluoroquinolona) relativamente nuevo en el mercado, liberado por la FDA en febrero de 1.998, con grandes espectativas y lanzado por el famoso laboratorio PFIZER,

Un año despues ya se habian reportado 140 CASOS DE TOXICIDAD HEPATICA, en algunas casos requiriendo de transplante de higado y muerte con SOLO TRES DIAS DE TRATAMIENTO. LA FDA RECOMENDO SU SALIDA DEL MERCADO EN JUNIO 1.999. 

Lo mas RARO de TODO ESTO es que TROVAN FUE LANZADO AL MERCADO con unos estudios PRELIMINARES donde NUNCA HUBO EFECTOS TOXICOS EN EL HIGADO. En Nuestro pais fue retirado APENAS 2 MESES DESPUES DE SU LANZAMIENTO


=============================================================
FDA ISSUES PUBLIC HEALTH ADVISORY ON LIVER TOXICITY ASSOCIATED WITH THE ANTIBIOTIC TROVAN
=============================================================
Source: The FDA

The Food and Drug Administration today issued a public health advisory to
physicians concerning the risks of liver toxicity associated with the use
of Trovan (trovafloxacin, an oral antibiotic) and Trovan-IV
(alatrofloxacin, the intravenous formulation of the drug). This action
follows postmarketing reports of rare but severe liver injuries leading to
transplants and deaths.
In issuing this advisory, FDA is informing physicians that Trovan should be
reserved for use only in patients who meet all of the following criteria:


Patients who have at least one of several specified infections such as
nosocomial (hospital-acquired) pneumonia or complicated intra-abdominal
infections that, in the judgment of the treating physician, is serious and
life- or limb-threatening; 
Patients who begin their therapy in in-patient health care facilities
(hospitals or longterm nursing care facilities); 
And patients for whom the treating physician believes that even given the
new safety information, the benefit of the product outweighs the potential
risks.
FDA is further informing physicians that, in general, therapy with Trovan
should not continue for longer than 14 days. Therapy should be discontinued
sooner if the patient experiences any clinical signs of liver dysfunction,
including fatigue, loss of appetite, yellowing of the skin and eyes, severe
stomach pain with nausea and vomiting, or dark urine.
FDA is also advising physicians that for most patients who meet the
treatment criteria, therapy would most likely begin with intravenous
Trovan. After clinical stabilization patients may be switched to the oral
dosage form. Although oral therapy might be appropriate in some cases as an
initial therapy, the agency emphasizes that the oral form of Trovan is not
warranted for infections other than those specified.

In addition, the manufacturer has agreed to limit distribution of the
product to hospitals and long-term nursing care facilities. The
manufacturer will be communicating in the near future with other
appropriate pharmacies to provide directions concerning possible return of
their present inventories of Trovan.

FDA is taking this action to reduce the potential risk from Trovan, while
at the same time preserving for physicians and patients alike the clinical
option of an effective broad-spectrum antibiotic for serious and life-
threatening infections. The agency considers this advisory an interim
measure until revised labeling for the product can be approved.

It is estimated that 2.5 million prescriptions have been written for
Trovan, a quinolone antibiotic, since its February 1998 market launch in
oral and intravenous formulations. Trovan was initially approved for
treating a broad range of infections, from minor skin infections to severe
infections in hospitalized patients.

No reports of liver failure, liver transplant, or death due to liver
problems were reported in the 7,000 patients studied in premarketing
clinical trials for Trovan. In July 1998, FDA worked with the manufacturer
to strengthen the product's labeling concerning liver problems after
receiving reports of elevated liver enzymes and symptomatic hepatitis in
patients after short- and long-term therapy. Since then, FDA has continued
to receive reports of liver toxicity, including reports of a more serious
nature.

FDA is now aware of 14 cases of acute liver failure that it has concluded
are strongly associated with the drug. Six of these patients died: five due
to liver failure and one of four additional patients who received liver
transplants. Three patients recovered without requiring liver transplants,
and for the remaining two patients the final outcome is still pending. 

More information about Trovan, including FDA's public health advisory, is
available on the World Wide Web at www.fda.gov/cder/news/trovan/default.htm
and from Pfizer, the manufacturer of the drug, at 1-800-438-1985. 

The FDA asks that any adverse events associated with Trovan be reported to
the agency through MedWatch, FDA's adverse event reporting system. Reports
may be submitted to FDA by telephone (800-332-1088), by fax (800-332-0178)
or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20857.
Reports can also be filed via the internet at www.fda.gov/medwatch. Reports
may also be filed directly to the manufacturer. 


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5.) THE ASTEMIZOLE (HISMANAL), (Lab JANSSEN-CILAG Pharmaceutica).

The ASTEMIZOLE, drugs of the ANTIHISTAMINE group, it was thrown to the market in the year 1.998 in the United States. One year later RETIRED OF THE MARKET FOR the same laboratory JANSSEN in June of 1.999, 21 due to the adverse effects reported among them the Heart events being described arrhythmias and deaths mainly. 


 EL HISMANAL (ASTEMIZOLE): Laboratorio JANSSEN-CILAG Pharmaceutica
-----------------------------------------------------------------------
El ASTEMIZOLE, droga del grupo de los ANTIHISTAMINICOS, fue lanzado al mercado en el año 1.998 en los Estados Unidos. Un año despues RETIRADO DEL MERCADO POR el mismo laboratorio JANSSEN el 21 de Junio de 1.999, debido a los efectos adversos reportados entre ellos los eventos Cardiacos describiendose principalmente arritmias y muertes. 

==============================================
JANSSEN PHARMACEUTICA ANNOUNCES
THE WITHDRAWAL OF HISMANAL FROM THE MARKET
==============================================
June 21, 1999 
Janssen Pharmaceutica, Inc., of Titusville, N.J., has announced that it is
voluntarily withdrawing the prescription antihistamine, Hismanal
(astemizole) 10 mg., from the market.
Since the drugís approval in 1988, new adverse reaction data has required a
series of labeling changes and warnings. In light of the choices of other
prescription antihistamines now available, and the overall risk benefit
profile of this drug, FDA supports the decision of the company to withdraw
the product.

Patients who have been taking Hismanal for their allergy symptoms should
consult with their doctors to determine an appropriate alternative treatment


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6.) THE PROPULSID /PREPULSID (CISAPRIDE), (Lab JANSSEN-CILAG).


Another drug of the laboratory Janssen Pharmaceutica, thrown to the market in 1.993 for the treatment of the gastric reflux with big hopes. For December 31 1.999, 341 cases of heart arrhythmias had been reported, including 80 deaths. For January of year 2.000 Janssen makes an effort to inform on the risk of the handling of the drug.

For JULY 2.000, The product licence for cisapride (Prepulsid), a drug used to treat gastric and digestive disorders in adults and children, has been suspended by the Medicines Control Agency after five (5) DEATHS in the United Kingdom and 125 DEATHS WORLDWIDE that are thought to be associated with the drug.

For April 12- 2.001 Janssen Pharmaceutica decides to retire of the market the drug to avoid bigger problems. 

 EL PREPULSID (CISAPRIDE): Laboratorio JANSSEN-CILAG Pharmaceutica
------------------------------------------------------------------------------
Otra droga del laboratorio Janssen Pharmaceutica, lanzada al mercado en 1.993 para el tratamiento del reflujo gastrico con grandes espectativas. Para el 31 de diciembre de 1.999 se habian reportado 341 casos de arritmias cardiacas asociadas al uso de esta droga, incluyendo 80 muertes. Para enero del año 2.000 Janssen hace un esfuerzo para informar sobre los riesgos del manejo de la droga. 

La Agencia de Control de Medicinas del Reino Unido decide suspender la licensia para la venta y comercializacion del CISAPRIDE en JULIO del 2.000, producto para tratar desordenes gastricos y digestivos en niños y adultos, despues del reporte de 5 MUERTES, en el REINO UNIDO Y 125 MUERTES REPORTADAS EN EL MUNDO, asociadas al uso de esta droga.

Para el 12 de Abril de 2.001 Janssen Pharmaceutica decide retirar del mercado la droga para evitar mayores problemas. 
==========================================
New Safety Recommendations for Use of Cisapride (Propulsid)
==========================================
Source: Harvard Heart Letter
April 2000 

Heart Lines

This month the Food and Drug Administration will hold a public advisory committee meeting to further discuss the safety of cisapride (Propulsid) and how to reduce the chances that someone will experience a severe adverse event from this drug.

The FDA first approved cisapride in tablet form in 1993 and then in liquid form in 1995. It is used to treat severe nighttime heartburn, usually due to gastroesophageal reflux disease (a condition where the band of muscle that prevents stomach acid from leaking back into the esophagus relaxes spontaneously, creating a painful heartburn-like sensation). Many drugs used to treat this condition suppress production of stomach acids. Cisapride works a little differently, moving the harmful acids through the digestive tract thereby preventing their painful reflux into the esophagus. Because this drug can be risky, it is generally reserved for use in patients who have not responded well to lifestyle changes or other medications used to manage gastroesophageal reflux disease.

In June 1998, several reports of serious adverse reactions in patients taking cisapride prompted the FDA to issue a warning about the drug. The medical problems included heart-rhythm disorders and death (most often occurring in people with certain health problems or who were taking other medications). Although it could not find a direct link between the reported problems and cisapride, the FDA did strengthen the precautions for use of this drug. A more recent analysis of 270 adverse event reports (including 70 deaths) suggests that roughly 85% of these cases were patients with these identifiable risks.

In January 2000, the FDA bolstered its efforts to reduce the likelihood of complications from cisapride by recommending that physicians consider performing an electrocardiogram and certain blood tests before prescribing it. New labeling lists drugs and underlying conditions that put patients at increased risk. Cisapride should not be used by patients taking some of the following types of medications: anti-allergy, anti-angina, anti-arrhythmics (to treat an irregular heart rhythm), antibiotics, antidepressants, anti-fungals, anti-nausea, antipsychotics, and protease inhibitors (to treat HIV infection). Also, patients with any of the following conditions should not take the drug: history of irregular heartbeats; abnormal electrocardiogram; heart disease; kidney disease; lung disease; low potassium, calcium, or magnesium levels; an eating disorder (such as bulimia or anorexia); dehydration or persistent vomiting.


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 7.) THE VIOXX (ROFECOXIB), Laboratory MERCK S. and D.

The drug VIOXX ROFECOXIB) rushed to the market in the years 2.000, after one year it presents 1.000 reports of adverse reactions for their use including 11 deaths reported in ENGLAND. The effects but commonly reported they were: 
Gastrointestinal adverse reactions account for almost half (554) of the reports, of which the majority (84%) were nauseates, dyspepsia, diarrhoea and abdominal pain, the agency said. However there have been 68 reports (12%) of upper GI perforations, ulceration and bleeds (PUBs). Forty-four (65%) of the patients with PUBs recovered, although five had to fatal outcome." 

The agencies also received 177 reports of cardiovascular suspected reactions, including 101 reports of oedema, 31 reports of hypertension and 19 reports of palpitations. There were 15 reports of cardiac failure, three of which had to fatal outcome, and nine reports of myocardial infarction, three of them fatal. In the majority of these, the patient had risk factors for 
cardiovascular disease. 

Psychiatric reactions were also reported, including 28 reports of depression, 14 reports of confusion and 11 reports of hallucinations. Adverse reactions recognised with other NSAIDs were also reported with rofecoxib. These included angioedema (35 reports), bronchospasm or exacerbation of asthma (25), renal failure (16), and abnormal hepatic function (12). 

THE FDA ALSO RECENTLY NOTICED TO THE LABORATORY MERCK S. AND D. the problems of their molecule VIOXX it was CAUSING IN THE HEALTH OF THE PATIENTS, MAINLY MYOCARDIAL INFARCTION. 

But NOBODY PAID ATTENTION TO THESE WARNINGS until some few weeks ago 30 SEPTEMBER 2.0004 when the SAME LABORATORY already DECIDED to take it out of the market for the problems mentioned, almost 3 years after I MADE THIS WARNING in THE DERMAGIC/EXPRESS.

By the way MERCK one comes WITH A NEW MOLECULE: ARCOXIA, not yet approved by the FDA, if it is a COX-2 molecule, it will BE MORE OF THE SAME thing.


Merck Announces Voluntary Worldwide Withdrawal of VIOXX®
Source: Http://healthorbit.ca/

[email protected] <[email protected]>

WHITEHOUSE STATION, N.J., Sept. 30, 2004 - Merck &. Co., Inc. today
announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis
and acute pain medication. The company's decision, which is effective immediately,
is based on new, three-year data from a prospective, randomized, placebo-
controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on
VIOXX) trial.

5.)
Merck Halts Vioxx Sales on Health Threats

Source: http://www.abcnews.go.com/

Merck Pulls Vioxx Arthritis Drug From Market on Heart Attack, Stroke
Concerns; Stock Plunges

The Associated Press

TRENTON, N.J. Sept. 30, 2004 — Merck & Co. is pulling its blockbuster Vioxx
from the market after new data found the arthritis drug doubled the risk of heart
attacks and strokes. Merck's stock plunged almost 27 percent as the
pharmaceutical giant said the recall will hurt its earnings.
Merck said Thursday the clinical trial data showed an increased risk of heart attack
and other cardiovascular complications 18 months after patients started taking
Vioxx, which also is prescribed for acute pain and disorders such as carpal tunnel
syndrome.

The three-year study aimed at showing that Vioxx could prevent the recurrence of
polyps, which can turn cancerous, in the colon and rectum was stopped after
Merck discovered participants had double the risk of a heart attack compared to
those taking a placebo.

By Thursday afternoon, at least one plaintiffs' attorney announced plans for a class
-action lawsuit against Merck. Another claimed to represent 58 patients around the
country allegedly harmed by Vioxx, including people who suffered a heart attack,
stroke, internal bleeding or kidney failure.

"It's a disaster for Merck, coming at the worst time," said independent health care
analyst Hemant Shah of HKS & Co. in Warren, N.J.

About 2 million people worldwide use Vioxx, Merck said, and 84 million have
taken it since it came on the market with great fanfare in 1999. It is one of Merck's
most important drugs, with $1.8 billion in U.S. sales in 2003 and global sales of $2
.5 billion 11 percent of the company's $22.49 billion in revenue that year.

But Vioxx sales dipped 18 percent in the second quarter of this year to $653
million, partly due to increasing concerns about an elevated risk of heart
complications.

Medical experts advised patients Thursday to stop taking Vioxx and consult their
doctor about alternatives.

Merck said the recall will slash about 50 cents to 60 cents a share from its earnings
for the rest of this year. That includes foregone sales, writeoffs of inventory held by
Merck, customer returns of product previously sold and other costs of the
pullback. Merck expects foregone fourth quarter sales of Vioxx of $700 million to
$750 million alone.

Merck, based in Whitehouse Station, N.J., had previously been expecting 2004
earnings per share of $3.11 to $3.17.

"We're taking this action because we believe it best serves the interest of patients,"
Ray V. Gilmartin, Merck's chairman, president and chief executive, said in a
statement.

Shares in Merck, the world's third-biggest drug maker, plunged $12.07, nearly 27
percent, to close at $33.00 on the New York Stock Exchange. That wiped out $
28 billion in market value. More than 140 million shares were traded, compared to
a daily average below 10 million.

Shah said for Merck, the Vioxx withdrawal comes "at a time when they really need
to get ready for expiration" of its patent for Zocor, the cholesterol treatment that is
the company's top-selling drug.

Zocor loses patent protection early in 2006 and sales are expected to plunge
against generic competition. In an effort to replace those revenues, Merck recently
launched a drug with Schering-Plough Corp., Vytorin, that combines Zocor and
Schering-Plough's Zetia to attack cholesterol levels in two complementary ways.

The Vioxx recall stands to benefit Pfizer Inc., the world's biggest drugmaker.
Merck and Pfizer have been battling for market share, with Pfizer's Celebrex
arthritis drug dominating the market with about $5 billion in U.S. sales alone last
year. Pfizer shares were up 35 cents to $30.53 in afternoon trading on the NYSE.

Pfizer issued a statement Thursday citing the "outstanding long-term safety profile"
of Celebrex and saying that in a recent FDA-sponsored study of 1.4 million
patients, those who received Celebrex demonstrated no increased risk of cardiac
trouble.

Vioxx was labeled with a warning about heart risks in 2001 after Merck's own
study in 2000 uncovered the increased risk of heart attack and other complications.
The Food and Drug Administration has been monitoring problems reported to it
since then.

"This is not a total surprise," said Dr. Steven Galson, acting director of the FDA's
Center for Drug Evaluation and Research.

Dr. Steven Abramson, director of rheumatology at New York University Hospital
for Joint Diseases, said "there are very few patients for whom there won't be a
good alternative drug."

Besides generic anti-inflammatory drugs such as ibuprofen, naproxen and aspirin,
those include Celebrex, which Abramson said has not been linked to heart
complications.

Celebrex and its successor drug, Bextra, as well as Vioxx and a successor drug
called Arcoxia that is awaiting FDA approval, are part of a class of anti-
inflammatory drugs touted by the pharmaceutical industry as being more effective
and having less side effects, particularly on the gastrointestinal system, than older
drugs.

Vioxx's removal will be a blow to hopes that it and other drugs in the class known
as COX-2 inhibitors could be used to prevent cancer in people at high risk of
developing it. A landmark study in 2002 showed that small, daily doses of aspirin
could prevent colon cancer, and studies hinted that COX-2 inhibitors might do the
same possibly without aspirin's side effects.

All COX-2 inhibitors can raise blood pressure, but Vioxx appears to be the only
one that's been linked to higher risk of heart attacks and strokes, Galson said.

Merck is scheduled to release financial results for the third quarter, which ends
today, on Oct. 21.

EL VIOXX (ROFECOXIB): Laboratorio MERCK S. and D. 
-------------------------------------------------------------------
La droga VIOXX ROFECOXIB) lanzada al mercado en el años 2.000, despues de un año presenta 1.000 reportes de reacciones adversas por su uso incluyendo 11 muertes reportadas en INGLATERRA. Los efectos mas comunmente reportados fueron: 

Gastrointestinales: nausea, dispepsia, diarrea, dolor abdominal, ulceras y sangramientos del tracto gastrointestinal superior, (68) reportes (12%) con 5 muertes. 

Las agencias recibieron tambien 177 reportes de reacciones cardiovasculares, incluyendo 101 reportes de edema, 31 reportes de hipertension y 19 reportes de palpitaciones. Hay 15 reportes de falla cardiaca, 3 de ellos murieron, y 9 reportes de infarto al miocardio, 3 de ellos murieron. 

Tambien han sido reportados recciones psiquiatricas: 14 reportes de confusion y 11 reportes de halucinaciones. Otros: angiodema, 35 reportes, broncoespasmo o exacerbacion de asma, 25 reportes, 16 reportes de falla renal y 12 de funcion hepatica anormal. 

LA FDA TAMBIEN RECIENTEMENTE ADVIRTIO AL LABORATORIO MERCK S. AND D. los problemas qu su molecula VIOXX ESTABA PROVOCANDO EN LA SALUD DE LOS PACIENTES principalmente el INFARTO AL MIOCARDIO.

Pero NADIE HIZO CASO A ESTAS ADVERTENCIAS hasta que hace unas pocas semanas 30 SEPTIEMBRE 2.004 el MISMO LABORATORIO DECIDIO sacarlo del mercado por los problemas ya antes mencionados, casi 3 años despues que YO HICIERA ESTA ADVERTENCIA POR EL DERMAGIC/EXPRESS.

POR CIERTO MERCK se viene CON UNA NUEVA MOLECULA: ARCOXIA,,,, no esta aprobada aun por la FDA, si es una MOELCULA COX-2,,, SERA MAS DE LO MISMO !

=====================================================
Merck retira ‘Vioxx’ del mercado por incremento del riesgo cardiovascular en uso prolongado.
===================================================
Source: www.correofarmaceutico.com/

La multinacional Merck, que opera como MSD en Europa, retiró ayer del
mercado su fármaco superventas Vioxx (rofecoxib), inhibidor selectivo de la
COX-2, indicado para el tratamiento sintomático de la artritis reumatoide y de la
artrosis y comercializado como Ceoxx en España para el tratamiento sintomático
del dolor agudo a corto plazo, por su riesgo incrementado de accidente
cardiovascular grave en tratamientos prolongados.

Valvanera Valero

Los nuevos datos del perfil de seguridad del Vioxx se han obtenido en un ensayo
clínico de rofecoxib frente a placebo para estudiar si previene la recurrencia de pó
lipos colorrectales en pacientes con historia de adenomas colorrectales. A partir de
los 18 meses de toma diaria de 25 mg de rofecoxib, los pacientes presentaron un
número de eventos cardiovasculares superior a placebo (45 frente a 25).

La Agencia Española del Medicamento y Productos Sanitarios (Aemps) recuerda
en una nota informativa de comunicación de riesgos de medicamentos para los
profesionales sanitarios que “la seguridad cardiovascular de rofecoxib y de otros
coxibs ha sido revisada en repetidas ocasiones por las agencias reguladoras
nacionales desde la publicación del ensayo clínico Vigor, en el que se observó que
rofecoxib, a dosis de 50 mg (entre 2 y 4 veces la recomendada) se asocia a un
incremento de riesgo de infarto agudo de miocardio comparado con naproxeno,
AINE no selectivo”. Entonces, dice la Aemps, “aunque no pudo resolverse si este
resultado se debía a un incremento de riesgo de rofecoxib o a un efecto protector
de naproxeno, se procedió a modificar la información del medicamento dirigida a
los profesionales y los pacientes para advertir de estos resultados”. Posteriormente,
según la agencia, se han publicado varios estudios donde se observaba un
incremento de riesgo pero solo a dosis superiores a 25 mg.

La AEMPS insiste en que “los datos se refieren únicamente a rofecoxib y que no
pueden generalizarse a otros inhibidores selectivos de la COX-2”. Y aconseja que
aunque los riesgos detectados sólo ocurren tras un tratamiento prolongado (más de
1 año) con Vioxx, se recomienda la suspensión del mismo puesto que es fácilmente
sustituible por tratamientos alternativos sobre los cuales el médico de familia podrá
determinar la alternativa más adecuada a las necesidades de los pacientes.

Vioxx facturó en 2003 2.300 millones de euros en el mundo y desde enero de
2004, 20 millones de euros en España. En los últimos doce meses se han tratado
en España 277.000 pacientes con el fármaco, aunque no necesariamente en uso
crónico. Actualmente Sanidad estima que podría haber entre 70.000 y 100.000
pacientes en tratamiento con este fármaco, que requiere como otros coxibs visado
de inspección desde julio de 2002 en España. Ceoxx, sin embargo, no está
cubierto por la seguridad social.


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8.) THE AULIN (NIMESULIDE), ( Lab. Shering-Plough and others).

Data-Medicos 
Dermagic/Express No. 3-(110) 
15 December 2.001

THE NIMESULIDE considered a "PREFERENTIAL" INHIBITOR on  
THE CYCLOOXYGENASE 2 (COX-2). Has not been described the PROTROMBOTIC EFFECTS THAT are ATTRIBUTED to the molecules " COXIBS ", CELEBEREX AND VIOXX, But its HIGH HEPATIC TOXICITY AND OTHER ADVERSE EFFECTS make of this molecule COX-2 a true risk for THE HUMAN HEALTH. 

THIS molecule was NEVER APPROVED FOR ITS COMMERCIALIZATION IN USA, and it will PROBABLY NEVER BE APPROVED BY THE FDA, but if it was approved in some EUROPEAN countries, ASIA AND LATIN AMERICA. Is in the market from 1988. 

THE " POT " OR PIPE OF THE NIMESULIDE AND THEIR FATAL ADVERSE EFFECTS were UNCOVERED IN PORTUGAL WHERE the Dr Figueira and colleagues describe a case of toxic FULMINANT hepatitis in 1998, then 2 cases of the REYE SYNDROME were described WITH FATAL OUTCOME, and 17 TYPES OF ADVERSE EFFECTS STANDING OUT THE HEPATIC ones AND DERMATOLOGICS. This resulted in that THE AULIN (NIMESULIDE) PEDIATRIC it was WITHDRAWAL IN PORTUGAL, I REPEAT THE PEDIATRIC AULIN it was PROHIBITED IN PORTUGAL FROM APRIL OF 1.999. 

AT THE MOMENT it is highly questioned in OTHER COUNTRIES LIKE GERMANY, SWEDEN, THE INDIAN AND IN OUR COUNTRY VENEZUELA, because in a newspaper "THE NEW COUNTRY" was QUESTIONED THE DRUG FOR A PEDIATRICIAN, he NOTICED THE ADVERSE EFFECTS OF THE SAME one. 

IN two previous revisions on this molecule have HIGHLIGHTED WITH ACCURACY ALL THE NOXIOUS EFFECTS OF THE NIMESULIDE 

To CONCLUDE THIS REVISION, I MAKE A CALL to the doctors and dermatologist of the world to not prescribing THESE MOLECULES. WE ARE NOT TO THE SERVICE OF THE INTERESTS OF THE LABORATORIES, we are AND we EXIST to GIVE HEALTH TO OUR PATIENTS, AND WITH THE PRESCRIPTION OF THESE 3 MOLECULES, CELEBREX, VIOXX AND AULIN, we are PUTTING IN RISK THE HEALTH OF THEM. 

PEDIATRICIANS, DERMATOLOGIST AND DOCTORS OF THE WORLD, let us TO TELL HIM A FIRM "NOT OR NEGATIVE" TO THESE MOLECULES!!! and let us educate to our patient ones and let us don't PARTICIPATE IN THOSE "MORTAL" DANCE MILLIONAIRE OF THESE LABORATORIES. 

..." ALL MOLECULE HAS ITS PEAK AND FALL, THESE they FELL FOR ITS OWN WEIGHT, PEOPLE'S WEIGHT THAT he has DIED FOR USE THEM..." 

Data-Medicos 
Dermagic/Express No. 5-(120) 
30 September 2.003 

The recent nimesulide evaluation for the European Agency for the Evaluation of
Medicinal products (EMEA) OF the molecule NIMESULIDE for their use in patient
that they suffer a wide variety of inflammatory and painful conditions, following a 16-month-long evaluation of the molecule’s benefit/ risk profile gives as FINAL conclusion after the bad NEWS began to arrive on adverse effects of the MOLECULE. The EMEA has prohibited its use simultaneously in the children under 12 years of age. EUROPEAN AGENCY FOR THE EVALUATION DE MEDICINAL PRODUCTS.

Dermagic Express one scores TREMENDOUS VICTORY after a long battle that
beginning in a year 2.001 DENOUNCING THE ADVERSE EFFECTS of this molecule
and their hepatic toxicity, in children and adult. This PUBLISHED news IN
INTERNET THE DAY AUGUST 28 of year 2.003 are a HISTORICAL DATE for the one
DERMAGIC EXPRESS, and the children of the world that will never receive the noxious effects of this medicin.

Many said that this molecule was ONE of THE MARVELS of the century, but never been licensed for use in developed economies like US, Canada, UK, Australia, New Zealand and Scandinavian countries. Small countries like Portugal, Israel and our neighbours Sri- Lanka and Bangladesh have shown the guts and grit to withdraw the drug. Nimesulide was withdrawn in 2002 by the innovator, Boehringer from Spain and Finland. The European Union has recently issued a precautionary advice on the marketing of this drug following serious complications after its use.

THE EMEA, EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS. he also suggests the doctors to restrict THE USE OF NIMESULIDE
IN ADOLESCENTS.

In VENEZUELA it continues being sold, let us wait that the sanitary authorities of the country
take conscience and take out of the market this medicine for their high risk
in children. the DERMAGIC it has already PUBLISHED IT IN OTHER OCCASIONS.

THE FALL OF THE NIMESULIDE is a total reality , it is question of time so that
be also prohibited in adults.

DERMAGIC EXPRESS PIONEER OF THIS FIGHT against the NIMESULIDE,
marketed in venezuela under the brand NAMES: AULIN, AINEX, SCAFLAN,
NORMOSILEN, and other, wants to thank to all the AUTHORITIES of EUROPE that
they took conscience in this MOLECULE and they make this HISTORICAL RESULUTION
Don't PRESCRIBE NIMESULIDE TO YOUR SON below of 12 YEARS!!!! neither to
ADOLESCENTS.

THE NIMESULIDES WAS MOVEDA AWAY OUT FROM THE MARKET IN VENEZUELA THE day 07 JANUARY 2.005,,, ANOTHER DIRTY DOZEN MOLECULE

Data-Medicos 
Dermagic/Express No. 3-(110) 
15 Diciembre 2.001

EL NIMESULIDE considerado un INHIBIDOR "PREFERENCIAL" SOBRE  
LA CICLOOXIGENASA 2 (COX-2). No se le han descrito los EFECTOS PROTROMBOTICOS QUE SE LE ATRIBUYEN a las moleculas "COXIBS", CELEBEREX Y VIOXX y otras nuevas, Pero su ALTA TOXICIDAD HEPATICA Y OTROS EFECTOS ADVERSOS hacen de esta molecula COX-2 un riesgo verdadero para LA SALUD HUMANA. 

ESTA molecula NUNCA SE APROBO PARA SU COMERCIALIZACION EN USA, y PROBABLEMENTE NUNCA SERA APROBADA POR LA FDA, pero si fue aprobada en algunos paises EUROPEOS, ASIA Y LATINOAMERICA. Esta en el mercado desde 1988. 

LA "OLLA" O CAÑERIA DEL NIMESULIDE Y SUS FATALES EFECTOS ADVERSOS FUE DESTAPADA EN PORTUGAL DONDE el Dr Figueira y colegas describe un caso de hepatitis toxica FULMINANTE en 1998, luego se describieron 2 casos de SINDROME DE REYE CON DESENLACE FATAL, Y 17 TIPOS DE EFECTOS ADVERSOS DESTACANDOSE LOS HEPATICOS Y DERMATOLOGICOS. Esto trajo como consecuencia que EL AULIN (NIMESULIDE) PEDIATRICO FUERA DESCONTINUADO EN PORTUGAL, REPITO EL AULIN PEDIATRICO FUE PROHIBIDO EN PORTUGAL DESDE ABRIL DE 1.999. 

ACTUALMENTE es altamente cuestionado en OTROS PAISES COMO ALEMANIA, SUECIA, LA INDIA Y EN NUESTRIO PAIS VENEZUELA, pues en un periodico "EL NUEVO PAIS" FUE CUESTIONADA LA DROGA POR UN PEDIATRA donde ADVIRTIO LOS EFECTOS ADVERSOS DE LA MISMA. 

EN dos revisiones previas sobre esta molecula he DESTACADO CON EXACTITUD TODOS LOS EFECTOS NOCIVOS DEL NIMESULIDE 

PARA FINALIZAR ESTA REVISION, HAGO UN LLAMADO a los medicos y dermatologos del mundo a no prescribir ESTAS MOLECULAS. 

NOSOTROS NO ESTAMOS AL SERVICIO DE LOS INTERESES DE LOS LABORATORIOS, ESTAMOS Y EXISTIMOS PARA DAR SALUD A NUESTROS PACIENTES, Y CON LA PRESCRIPCION DE ESTAS 3 MOLECULAS, CELEBREX, VIOXX Y AULIN, ESTAMOS PONIENDO EN RIESGO LA SALUD DE ELLOS. 

PEDIATRAS, DERMATOLOGOS Y MEDICOS DEL MUNDO, DIGAMOSLE UN NO ROTUNDO A ESTAS MOLECULAS !!! y eduquemos a nuestros pacientes y NO PARTICIPEMOS EN ESAS DANZAS MILLONARIAS " MORTALES " DE ESTOS LABORATORIOS. 

TODA MOLECULA TIENE SU AUGE Y CAIDA, ESTAS CAYERON POR SU PROPIO PESO, EL PESO DE LA GENTE QUE HA MUERTO A COSTA DE ELLAS.

Data-Medicos 
Dermagic/Express No. 5-(120) 
30 Septiembre 2.003 / 30 September 2.003 

La reciente evaluación de nimesulide por la Agencia europea para la Evaluación de
Productos Medicinales (EMEA) DE la molecula NIMESULIDE para su uso en pacientes
que padecen una variedad ancha de condiciones inflamatorias y dolorosas, luego de una
LARGA EVALUACION de 16 meses acerca del beneficio de la molécula y el perfil de
riesgo da como conclusion FINAL despues que las noticias malas empezaron a llegar sobre
efectos adversos de la MOLECULA. El EMEA ha prohibido su uso simultáneamente en
los niños debajo de 12 años de edad. AGENCIA EUROPEA PARA LA EVALUACION
DE PRODUCTOS MEDICINALES.

Dermagic Express se anota TREMENDO TRIUNFO despues de una larga batalla que
inicio en al año 2.001 DENUNCIANDO LOS EFECTOS ADVERSOS de esta molecula
y su toxicidad hepatica, tanto en niños como adultos. Esta noticia PUBLICADA EN
INTERNET EL DIA 28 DE AGOSTO DEL 2.003 es una FECHA HISTORICA para el
DERMAGIC EXPRESS y los niños del mundo que nunca jamas recibiran los efectos nocivos de esta medicina

Muchos decian que esta molecula ERA UNA DE LAS MARAVILLAS del siglo, pero nunca fue aprobado en PAISES DESARROLLADOS como Estados Unidos, Canada, UK, Australia, Nueva Zelanda, y paises escandinavos, Pequeños paises como Portugal, Israel, Sri-Lanka y Bangladesh se quejaron y clamaron por el retiro de la droga. En el año 2.002 fue retirado de España y Finlandia por el innovador Boehringer. La union Europea recientemente habia advertido sobre las serias complicaciones del uso de esta droga.
 LA EMEA, AGENCIA EUROPEA PARA LA EVALUACION DE PRODUCTOS
MEDICINALES. tambien sugiere a los medicos restringir EL USO DE NIMESULIDE
EN ADOLESCENTES.

En VENEZUELA sigue vendiendose, esperemos que las autoridades sanitarias del pais tomen conciencia y saquen del mercado de una buena vez esta medicina por sus alto riesgo en niños, como ya el DERMAGIC LO HABIA PUBLICADO EN OTRAS OCASIONES.
LA CAIDA DEL NIMESULIDE ES una realidad total, solo es cuestion de tiempo para que sea prohibida en adultos tambien.

DERMAGIC EXPRESS PIONERO EN ESTA LUCHA contra el NIMESULIDE,
comercializado en venezuela bajo los NOMBRES DE AULIN, AINEX, SCAFLAN,
NORMOSILEN, y otros, quiere agradecer a todas las AUTORIDADES DE EUROPA quienes tomaron conciencia sobre esta MOLECULA y ejecutaron esta HISTORICA RESOLUCION.

NO LE MEDIQUES NIMESULIDE A TU HIJO MENOR DE 12 AÑOS !!!! ni a
ADOLESCENTES.

EL NIMESULIDE FUE SACADO DEL MERCADO VENEZOLANO EL 7 DE ENERO DEL 2.005...

OTRA MOLECULAS MAS DE LA DOCENA DEL PATIBULO...

==================================== 
Hypothermia with Nimesulide 
===================================== 
Letters to the Editor

Indian Pediatrics 2001; 38: 799-800 

Nimesulide is a new nonsteroidal anti-pyretic drug which is now commonly being used in pediatric practice. Some studies have shown a better antipyretic effect than para-cetamol and salicylates(1).

Nimesulide is considered to be a safe drug with no significant side effects. It can cause mild gastrointestinal symptoms, excessive perspiration, heart burn, flushing and skin rashes. Hematuria has recently been reported after administration of this drug(2).

I have observed hypothermia in six cases administrated Nimesulide recently in the age group of 6 months to 5 years. The temperature of one child fell to 94ºF (axillary) after giving a therapeutic dose (5 mg/kg/day with a measured cup in divided doses). The child, suffering from acute tonsillitis with a temperature of 105ºF, developed hypothermia after 2 hours of medication in the summer season. The mother complained of severe cold, shivering and ice cold skin. There was no sweating but mild tachycardia was recorded. Blood pressure and other vitals were within normal limits. The child was wrapped in a blanket. Intravenous fluids were given prophy-lactically and vitals were observed closely. The temperature improved after 5-6 hours. The therapeutic dose was repeated next time and the child again developed the same symptoms. Similar observations were made subsequently in 5 other children during a period of 10 months. This side effect of severe hypothermia has not been reported earlier.

Small children below 1 year of age should be given this drug cautiously. More observa-tions are required to substantiate hypothermia as a side-effect of nimasulide administration.

Sudesh Sharma,
Professor, Department of Pediatrics, 
Medical College, Amritsar, Punjab, India

References 

1. Capella D, Guerra A, Laudizi L, Cava. Zu TT. Efficacy and tolerability of nimesulide and lysine acetyl salicylate in the treatment of pediatric acute upper respiratory tract inflam-mation. Drugs 1993; 46: (Suppl 1): 222- 325.

2. Anandakesvasan TM. Nimesulide toxicity. Indian Pediatr, 1999; 36: 324. 

===============================
NIMESULIDE (PAEDIATRIC) 
===============================
Source: The WHO.

Application for an export licence refused

Portugal. The company Helsinn Pharmaceutical Products applied for an export licence for a paediatric formulation of nimesulide (Aulin Pediátrico, granules 50 mg), claiming that it intended to send the stock free of charge to East Timor for use in adults.

The application was refused because products containing nimesulide – including Aulin Pediátrico, granules 50 mg – were withdrawn from the market and the marketing authorizations were suspended on 24 March 1999 on the grounds that they were considered to present a public health risk. Under the terms of the decree they are also prohibited for export.

Reference: Communication from the Instituto Nacional da Farmácia e do Medicamento (INFARMED), Lisbon, 18 November 1999.

================================== 
Nimesulide-induced acute icteric hepatitis
==================================
S.P. Dourakis,1 V.A. Sevastianos,1 K. Petraki,2 S.J. Hadziyannis1 
1Academic Dept. of Medicine, “Hippokration” General Hospital, Athens School of Medicine, University of Athens, 
2Department of Pathology, “Hippokration” General Hospital, Athens, Greece 
PUBLISHED MONTHLY BY THE
SOCIETY FOR MEDICAL STUDIES
MARCH 2001 VOLUME 79 No 3

ABSTRACT Drug-induced hepatotoxicity has been reported infrequently with nimesulide. Isolated case reports of nimesulide hepatotoxicity range from the increase in transaminase levels to fatal acute liver injury. The case of a female 68 year old patient, who developed acute icteric hepatitis 15 days after the administration of nimesulide for symptomatic relieve from lumbar and lower extremities pain is described. Other causes of acute hepatocellular necrosis were excluded. Liver histology showed acute hepatitis changes with bridging necrosis. The drug was withdrawn. The patient recovered clinically and the serum bilirubin and aminotransferases levels gradually returned to normal in 9 weeks time. Acute hepatitis was probably caused by an idiosyncratic adverse reaction to one of nimesulide metabolites. In conclusion, this case strongly suggests that nimesulide may induce acute icteric hepatocellular necrosis which can be confused clinically with acute viral hepatitis. Administration of the drug must be immediatelly withdrawn in patients with tests, demonstrating a derranged liver function to prevent the development of acute liver failure. 

Key words Nimesulide, acute hepatitis, drug-induced liver disease. 

=======================================
Fatal hepatotoxicity secondary to nimesulide
=======================================
Source: © Springer-Verlag 2001
Eur J Clin Pharmacol, DOI 10.1007/s002280100312

Pharmacoepidemiology and Prescription

Giorgio Merlani1, Mark Fox2, Hans-Peter Oehen3, Gieri Cathomas3, Eberhard L. Renner2, Karin Fattinger4, Markus Schneemann1 and Gerd A. Kullak-Ublick2, 4, 

(1) Medizinische Klinik B, Department of Internal Medicine, University Hospital, 8091 Zurich, Switzerland 
(2) Division of Gastroenterology and Hepatology, Department of Internal Medicine, University Hospital, 8091 Zurich, Switzerland 
(3) Department of Pathology, University Hospital, 8091 Zurich, Switzerland 
(4) Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital, CH-8091 Zurich, Switzerland 

Abstract. This report describes a 57-year-old female patient with chronic lumbago, who died from the sequelae of acute liver failure induced by nimesulide medication. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) which preferentially inhibits cyclo-oxygenase 2 and has been associated with a total of 13 reported cases of severe liver injury including our case. On the basis of the literature reports, the following features of nimesulide-associated hepatotoxicity were identified: female sex (84% of cases), age (mean age 62 years), jaundice as a primary manifestation (90%) and the absence of peripheral blood eosinophilia. The average duration of therapy of the published cases was 62 days (range 7-180 days). Based on spontaneous reports to the World Health Organization, nimesulide induces a high proportion of severe adverse hepatic reactions compared with other NSAIDs registered in Switzerland. Hepatotoxicity thus represents an important risk factor of nimesulide usage.

Keywords. Hepatitis - Non-steroidal antiinflammatory drugs - Adverse drug reaction

E-mail: [email protected]
Phone: +41-1-2554097
Fax: +41-1-2554411 

==========================================
Re: Nimesulide and reasons for non-approval or withdrawal 
=========================================
Source: : www.essentialdrugs.org 

To: [email protected] 
Subject: [e-drug] Re: Nimesulide and reasons for non-approval or withdrawal (cont) 
From: helpline <[email protected]
Date: Mon, 30 Apr 2001 14:42:50 -0400 (EDT) 
Reply-To: [email protected] 
Sender: [email protected] 


E-drug: Re: Nimesulide and reasons for non-approval or withdrawal (cont)

Dear Dr. Maqsood,

Due to multiple reports of serious adverse drug reactions, pediatric 
nimesulide products have been suspended in Portugal as of April, 1999. Of 
the 17 reactions reported, the most frequent were dermatologic and hepatic 
in nature, including two cases of fatal Reyes syndrome. It is to be noted 
that concomitant therapy with other drugs (amoxicillin/clavulanic acid, 
lysine salicylate) in many of these cases prohibits a definitive causal 
link of the adverse reaction to nimesulide therapy. Further risk/benefit 
evaluation of pediatric nimesulide use is ongoing (Anon: SCRIP World 
Pharmaceutical News. PJB Publications, Ltd., London; No 2431, April 23, 
1999, p 20).

In Israel too, the drug has been banned for pediatric use. At the Drug 
Information Helpline, I have maintained a complete file on the drug 
through information on e-drug. I have read that in Sri Lanka, the Ministry 
of Health did a lot of investigation about registering the drug and finally 
decided not to.

I believe when more safer drugs as paracetamol are already available it is 
irrational to prescribe me-too drugs of doubtful efficacy.

helpline <[email protected]>

Send mail for the `E-Drug' conference to `[email protected]'.
Information and archive http://www.healthnet.org/programs/edrug.html
Mail administrative requests to `[email protected]'.
For additional assistance, send mail to: `[email protected]'.

===============================================
E-DRUG: Nimesulide
===============================================
Source: : www.essentialdrugs.org 

to: [email protected] 
Subject: E-DRUG: Nimesulide 
from: E-drug <[email protected]
Date: Sun, 18 Jul 1999 10:17:08 -0400 (EDT) 
Reply-To: [email protected] 
Sender: [email protected] 


E-drug: Nimesulide (cont)
-------------------------
[the Lancet (Volume 353, Number 9170 19 June 1999) discussed Nimesulide
as well. Interestingly, the Sri Lankese Regulatory Authority referred to
E-drug as one of its sources for deciding on the application of Nimesulide.
WB]

Registration of new drugs in developing countries

Sir--A Figueras and colleagues (April 24, p 1447) [1] describe fulminant
hepatic failure with nimesulide, a selective inhibitor of COX-2. They
also mention the difficulties associated with the registration of a new
drug in developing countries. Sri Lanka too has been confronted with this
issue. 

Nimesulide is registered in many countries (Spain, Italy, Portugal,
Switzerland, and Greece) and is the best selling pharmaceutical product
in Portugal.[2] There were six applications to the Sri Lankan Drug
Regulatory Authority (DRA) by various manufacturers in 1998. However,
nimesulide was not registered in Canada, the USA, the UK, Scandinavia,
Australia, and New Zealand. The Sri Lankan DRA considers these countries
to be the reference DRAs and tends to consider only those drugs (the
chemical entity, not the product) that are registered by these
authorities. 

Various arguments were given by the applicants to make nimesulide the
exception: it was an old drug, registered in Italy in 1985,[2] had been
assessed thoroughly, and there were many publications on it. A limited
literature search found more than 30 publications. Nevertheless, the Sri
Lankan DRA decided to be cautious and await further reports. This
decision was made easier by the fact that nimesulide did not have clear
advantages over other NSAIDs. 

During late 1998 and early 1999, there were reports of adverse events
with nimesulide.[2-4] None of the applicants for registration informed
the Sri Lankan DRA about these events. The DRA came to know about
fulminant hepatic failure with nimesulide through an e-mail discussion
group ("E-drug") in May. The paediatric nimesulide preparation has now
been withdrawn from sale in Portugal[3] and Israel.[4] These discoveries
were fortuitous--the DRA simply does not have the funds to subscribe to
medical journals or the personnel to monitor reports. Nimesulide is now
unlikely to be registered in Sri Lanka because of these reports. 

As Figueras and colleagues underline, the World Trade Organisation and
the International Conference on Harmonisation are driving the procedures
for registration of drugs. What should a developing country with little
or no information exchange, and inadequate regulation of drugs do, when
the harmonised dossiers of the new drugs are submitted for registration? 

In the few situations in which the new drug has a clear advantage over
existing drugs, it should properly be assessed and registered promptly.
However for the "me-too" drugs with no advantage over existing drugs,
which make-up most of the applications, such speed may not be needed.
There is a simple way to decide on "me-too" drugs; the approved product
information (indications, adverse effects) for an existing drug from a
reference DRA would show little or no difference from that of the newer
"me-too". Sri Lanka used this method and did not register mibefradil,[5]
the caution was well placed since the drug was subsequently withdrawn
worldwide. 

An important issue in registering new drugs in developing countries is
whether health or trade should come first. Registering new drugs without
delay would help trade and free circulation of goods; adopting a cautious
attitude would serve health. Should not the government ensure that
citizens are healthy before they begin to trade? 

K Weerasuriya 

*Department of Pharmacology, Faculty of Medicine, University of Colombo,
Colombo 00800, Sri Lanka; and Drug Evaluation Sub Committee Ministry of
Health, Colombo

email <<[email protected]>

1 Figueras A, Estevez F, Laporte J-R. New drugs, new adverse reactions,
and bibliographic databases. Lancet 1999; 353: 1447-48. 

2 Nimesulide ADR controversy in Portugal. Scrip 1999; no 2406: 8. 

3 Portugal suspends paediatric nimesulide. Scrip 1990; no 2431: 20. 

4 Israel nimesulide suspension inquiry. Scrip 1999; no 2434: 23. 

5 Weerasuriya K. Mibefradil: the sole exception. Lancet 1998; 351:
1829-30. 
--
Send mail for the `E-Drug' conference to `[email protected]'.
Mail administrative requests to `[email protected]'.
For additional assistance, send mail to: `[email protected]'.

===================================
PIL seeks ban on manufacture, sale of Nimesulide
===================================
Source: http://www.hindu.com/
By Our Staff Reporter


CHENNAI SEPT. 26. A public interest litigation petition seeking to ban the manufacture and sale of Nimesulide, a non-steroidal and anti-inflammatory drug, has been filed in the Madras High Court.

The First Bench comprising the Chief Justice, B. Subhashan Reddy, and Justice A. Kulasekaran, admitted the petition filed by the Tamil Nadu Health Development Forum, and ordered notices to the Union Health Secretary and the Drugs Controller-General of India.

The forum secretary and the former Director of the Institute of Child Health at the Government Children's Hospital here, C.S. Rex Sargunam, contended that though it was not an anti-fever drug it can bring down the temperature faster than other anti-fever drugs like paracetamol.

He said the drug could cause severe sideeffects. ``A person does not die of fever and joint pain, but dies of liver or kidney damage caused by the repeated use of Nimesulide''.

According to Dr. Sargunam it was the most expensive non-steroided anti-inflammatory drug and was not under the price control regime of the respondent-authorities.

In developed countries such as the United States, Britain, Canada and Australia, Nimesulide is not approved for use even for adults, whereas Finland, Spain, Turkey, etc., have banned the drug, the petition claimed.

Dr. Sargunam prayed for a direction to ban the manufacture and marketing of Nimesulide.

=============================================
Nimesulide again / banned its use in children below 12 years of age.
=============================================
Source: http://www.expresspharmapulse.com/
28th august 2003

THE recent evaluation of nimesulide by the European Agency for the Evaluation of Medicinal Products as safe and effective for use in patients suffering from a wide variety of inflammatory and painful conditions, following a 16-month-long evaluation of the molecule’s benefit/ risk profile must have come as much needed relief for its Swiss developer and licensor Helsinn Healthcare SA and Indian manufacturers who have been facing a downslide in market shares after bad news started spilling out. The EMEA has simultaneously banned its use in children below 12 years of age. The drug is available in India since 1995 and is among the largest prescribed NSAIDs in India and is one of the leading OTC products, too. According to a press release, 3 crore bottles of suspension have been sold in India since the introduction of the molecule. The release says about 18-20 lakh children are “getting relieved” from fever every month if the suspension sales data is converted into usage. Not a bad drug promotion idea, though.

The release, interestingly, does not talk about the ban on its administration to neonates, infants and children. It is interesting to note that paediatricians have a weakness for nimesulide suspensions after they diagnose children as suffering from fever which needs immediate management. The product has been so pushed by the manufacturers that doctors tend to prescribe three days of paediatric doses of the medicine which is supposed to be used only for two doses and be replaced by other medication if the fever shows no signs of subsiding. Doctors cannot be faulted for this as parents, in their anxiety to see the child back to normalcy, prod him to show quick results. So where the simple paracetamol could manage, doctors hand out a nimesulide prescription. Studies have talked about the harmful effects of nimesulide on the liver, but the Indian government has chosen not to act and place a fast-acting medicine on the black list. There are a few doctors who say that nimesulide should not be misused in children, but the majority feels otherwise. Indian doctors have used nimesulide more for its anti-pyretic properties than anti-inflammatory, whereas it is very well known that it is hepatotoxic. Blue Cross withdrew its paediatric suspensions of nimesulide from the market in the wake of the controversy, but others have not been so charitable. An Indian company, which developed a once-daily dosage form of nimesulide over an year back, is finding no international takers. This amply shows that global players no more factor nimesulide in their businesses. It is worrisome if the Indian government has chosen to ignore the controversy just because a section of the industry has embarked on an exercise to ensure that the highly profitable business continues without any hitch. It may not matter to the regulators as to how bad the chemical in the tablet is as long as the kid who pops it is not theirs. This is probably the attitude of the government and the bureaucracy.

==========================================
EMEA ban: Nimesulide market slips further
==========================================
Source: http://www.expresspharmapulse.com/
Jayashree Padmini - New Delhi 28 th August 2.003

Nimesulide manufacturers must be writhing in pain. The recent ban by The European Agency for Evaluation of Medicinal Products on use of nimesulide in children below 12 years of age has set the stage for another round of decline in its sales.

Add to that the EMEA restriction on the use of the NSAID with analgesic and anti-pyretic properties in adults, and you have the picture of a molecule needing a shot in the arm.

The Nimes-ulide market is already degrowing. It had a growth rate of seven per cent in October 2002 and is now degrowing at minus 10 per cent. Faster negative growth rates are predicted in the coming months, according to experts. Previously a growing molecule, Nimesulide has been witnessing a downtrend in sales over the past few months owing to the vast media outcry in the country.

Nimesulide, which proved its vulnerability to national opinion, will have to now face the repercussions of international angst apart from the domestic fall in sales.

In comparison to October 2002, the sale of Nise paediatric tablets (Dr Reddy’s) went down by 52.4 per cent and Nimulid paediatric tablets (Panacea Biotech) declined by 44 per cent.

The paediatric suspensions of these two brands witnessed a decline of 22 per cent and 29 per cent respectively.

It is not that the bad news has spared the adult dosages which are also feeling the heat Nise 100mg tablet witnessed a 26.3 per cent decline whereas Nimulid sales went down by 17 per cent.

The October 2002 moving annual turnover figure, according to retail market research firm AC Nielsen-ORG-MARG, for Nimesulide was at Rs 200 crore. It declined by 20 per cent by March 2003. Compared to March 2003, Nimesulide sales went down by around 17 per cent in June 2003. The market research firm’s MAT figure for March 2003 puts the Nimesulide sales at Rs 160 crore and, for June 2003, the figure is Rs 133 crore. Apart from the influence of media campaign against Nimesulide, the decline was attributed to the DCGI’s ban on Nimesulide drops and the discontinuation of Nimesulide combination products in the market by Dr Reddy’s.

DRL’s decision to withdraw Nimesulide combination drugs was influenced by the ongoing litigation in the Delhi High Court and the international market sensitivities, points out MIMS Editor Dr Chandra M Gulhati.

An opinion mobilisation in the US market against Indian companies selling drugs unauthorised by the DCGI could have detrimental impact on the market prospects of these companies, he said.

The PIL fled by Social Jurist, urging Delhi High Court to ban Nimesulide, particularly its use in children, was scheduled for hearing on August 27.

The issue of FDCs of Nimesulide will also be a focal point of the litigation since the DCGI has admitted that they were being manufactured under licences granted by state drug controllers without any marketing approval by the DCGI’s office.

The ban by EMEA on children below 12 could very well mean that physicians would restrain themselves from prescribing the drug to adolescents as well.

Further, the international agency restricts the use in adults to a few indications such as acute pain associated with osteoarthritis and dysmennorhoea only. Use in fever and pain, and inflammation associated with dental diseases is prohibited. Its topical form is to be used only for relief of pain due to sprains and acute inflammation of tendons due to injury (traumatic tendonitis).

EMEA announced its decision early this month after a 16-month long review of the controversial drug by experts drawn from European Union member states. The reference to EMEA for its adjudication was made by the National Agency on Medicines of Finland in April 2002. Earlier, countries like Finland, Spain and Portugal had suspended the use of Nimesulide in the wake of reports of its serious adverse effects on liver. In the Europe it was only Italy that has been allowing use of Nimesulide in children, but above the age of six years.


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9.) THE YASMIN (ANTICONCEPTIVE), (Lab. SCHERING Germany).

The great called birth-control pill YASMIN, of the GERMAN laboratory SCHERING rushed to the market in EUROPE in the year 2000 and that recently is marketing in Venezuela, it seems that is beginning to have PROBLEMS, in these FILES X of today's day demonstrates to all in a clear and simple way that NOT ALL THAT SHINES is GOLD. YASMIN is involved in events of THROMBOEMBOLISM with hardly 17 days of treatment and I have caused the death of a 17 year-old Dutch last year in Germany.
They have been described but of 4O CASES OF THROMBOEMBOLISM attributed to YASMIN, at level of legs and lung. The German Medical school he has decided that YASMIN is A PILL OF second generation because they are lacked epidemic data on its adverse effects on the THROMBOEMBOLISM. So dermagics friends be careful of this drug. !!!
It seems that the pill of the great well-being didn't fulfill its "slogan" and there is even a group of doctors that openly it has fixed position in the fact that YASMIN should NOT BE ANNOUNCED LIKE that! The new contraceptive, is a combination of DROSPIRENONE (a progestogen) and ETHINYLESTRADIOL.

 ANTICONCEPTIVO YASMIN (Laboratorio SCHERING ALEMANA)

La gran pildora anticonceptiva llamada YASMIN, del laboratorio SCHERING ALEMANA lanzada al mercado en EUROPA en el año 2000 y que recientemente se esta comercializando en Venezuela, parece que esta comenzando a tener PROBLEMAS, en estos EXPEDIENTES X del dia de hoy les demuestro de una manera clara y sencilla que NO TODO LO QUE BRILLA ES ORO. YASMIN esta involucrada en eventos de TROMBOEMBOLISMO con apenas 17 dias de tratamiento y causo la muerte de una joven de 17 años de tromboembolismo venoso hace un año en Alemania.

Se han descrito mas de 4O CASOS DE TROMBOEMBOLISMO atribuidos a YASMIN a nivel de piernas y pulmonares. El colego Medico de Alemania ha decidido que YASMIN ES UNA PILDORA DE segunda generacion porque se carecen de datos epidemiologicos sobre sus efectos adversos sobre el TROMBOEMBOLISMO. Asi que amigos dermagicos esten pendiente de esta droga. !!!

Parece que la pildora del gran bienestar no cumplio con su "slogan" e incluso hay un grupo de medicos que publicamente ha fijado posicion en el hecho de que YASMIN NO DEBE SER PROPAGANDEADA COMO TAL ! El nuevo anticonceptivo es una combinacion de DROSPIRENONA (un progestageno) y ETINILESTRADIOL

=====================================
Dutch GPs warned against new contraceptive pill
====================================
News

Tony Sheldon, Utrecht

Source:BMJ 2002;324:869 ( 13 April )

Dutch GPs are being advised by their own professional body not to prescribe a new low dose, monophasic oral contraceptive, marketed under the trade name Yasmin, until studies have established whether it is as safe as other contraceptive pills.

The new contraceptive, which is a combination of drospirenone (a progestogen) and ethinylestradiol, has been available in several European countries since 2000 and was approved by the US Food and Drug Administration last May. It is licensed for use in the United Kingdom, where it is being launched next week.

Last year a 17 year old Dutch girl who had been taking Yasmin died from a venous thrombosis. Although no direct link with Yasmin has ever been shown, 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal, have now been reported in Europe.

The Dutch College of General Practitioners has now reiterated its position that GPs should continue to choose the second generation pill, because of the lack of epidemiological data on the risk of thrombosis from Yasmin.

The Dutch Medicines Evaluation Agency, which has a leading role in the European Union in assessing the safety of Yasmin, has as a result of the two deaths asked that the drug carry a warning that the risk of venous thrombosis from using it remains unknown. Before licensing Yasmin the agency had also asked for more research into side effects and coagulation. Final results from a comparative study over three years involving 3000 women have yet to be published.

The agency said: "The impression exists that GPs are inclined to prescribe the new pill earlier in the assumption that the risk of venous thrombosis is smaller than with the second and third generation of contraceptive pill," but added that this cannot be concluded from the available data.

Speaking on a Dutch radio station, Frits Rosendaal, professor of clinical epidemiology at Leiden University Medical Centre, called for GPs not to prescribe Yasmin until the risk of venous thrombosis was known.

He said: "I am not satisfied it is absolutely safe." He was alarmed that as many as 40 cases have been reported voluntarily by doctors so soon after Yasmin was registered. "Doctors seem to believe it is safer, but we don't know. We are making the same mistake as with the third generation contraceptive pill."

Yasmin's manufacturer, the German pharmaceutical company Schering, is "absolutely convinced of the safety of Yasmin." It has written to all Dutch GPs, gynaecologists, and pharmacists, saying that the 40 reported cases of venous thrombosis among a million users of Yasmin, mainly in Europe, do "absolutely not indicate an increased risk of venous thrombosis."

A Schering senior medical adviser, Dr Egbert Klaassen, said the company had conducted all the necessary research acceptable to the Medicines Evaluation Agency and the FDA. Interim results from Schering's post-marketing surveillance study of a million cycles show that, after one year, one venous thrombosis occurred among Yasmin users, compared with five among users of other oral contraceptives.

Yasmin has been licensed in Europe since November 2000. Schering estimates that about 35000 women are using it in the Netherlands and 500000 throughout 17 countries in Europe


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10.) THE CELEBREX (CELECOXIB), (Lab PFIZER).

THE CELEBREX (CELECOXIB) the other drug of the GROUP OF THE "COXIBS" HAS in its to have but of 90 REPORTED ADVERSE EFFECTS ASSOCIATED TO ITS USE: among them highlighting the MYOCARDIAL INFARCTION. 

Him but interesting of these molecules it is an a I article also published in the WALL STREET JOURNAL, and published in the NEWSPAPER THE NATIONAL one IN OUR COUNTRY, UNDER THE I TITLE: AN IRONY to BE TREATED OF An ARTHRITIS to DIE FROM THE HEART, where it is said that the laboratory HID RESULTS of studies where it was in EVIDENCE THE PROTHROMBOTIC EFFECT AND PREJUDICIAL FOR THE HEART. 

The laboratory PFIZER IN OUR COUNTRY WAS GIVING FOR THAT YEAR A COMMUNICATION DISQUALIFYING THE PUBLISHED STUDY IN THE JAMA that was the one that UNCOVER THE ROTTEN PIPE, of this MEDICATION. I told to the visitor THAT the study was A SERIOUS ONE AND THAT they ALSO EXISTED OTHER WHERE it was DEMONSTRATED THAT VIOXX AND CELEBREX have a EVIDENT PROTHROMBOTIC EFFECT.

FOR SEPTEMBER 30 the 2.004 THE VIOXX (ROFECOXIB), molecule almost sister of the CELEBREX (CELECOXIB) it was moved away of the market by the same laboratory MERCK being demonstrated that the heart events were really related with the use of this molecule...

The Celeberex 90 Side Effects: 

MAINLY

Risk of Cardiovascular events: Myocardial infarction, unstable angina, Cardiac Thrombus, resuscitated cardiac arrest, sudden or unexplained death, ischemic stroke, and transient ischemic attacks. 

OTHER SIDE EFFECTS:

The following occurred in 0.1-1.9% of patients regardless of causality-note this is an extremely low per cent of side effects.

GI- constipation, diverticulitis, gastritis, gastroenteritis, hemorrhoids, hiatal hernia, stomatitis, vomiting

CV - aggravated high blood pressure, dry mouth, glaucoma

General: allergy aggravated, allergic reaction, chest pain, swelling generalized, face swelling, fatigue, fever, hot flashes, flu-like syndromes, pain, peripheral pain

CNS, PNS- leg cramps, migraine, neuralgia, neuropathy, paresthesia, vertigo

Female reproductive- breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhea, menstrual disorder, vaginal hemorrhage, vaginitis

Male reproductive- prostatic disorder

Hearing and vestibular: deafness,ear abnormality, earache, tinnitus

Heart rate and rhythm: angina pectoris, coronary artery disorder, myocardial infarction, palpitation, tachycardia

Liver and biliary system: hepatic function abnormal

Metabolic and nutritional: kidney and liver function changes, DM, high cholesterol, high blood sugar, low potassium, weight increase

Musculoskeletal: Arthralgia, arthrosis, bone disorder, fracture accidental, neck stiffness, painful joints, tendinitis

Platelets: nose bleeds, bruising

Psychaiatric: anorexia, anxiety, appetite incnreased, depression, nervousness, somnolence

Hemic: anemia

Respiratory: bronchitis, trouble breathing, aggrevated, coughing, dyspnea, laryngitis, pneumonia

Skin & appendages: hair loss, dermatitis, nail disorder, sensitivity to light, itching skin, rashs, skin dry, sweating increased,

Special senses: taste changes

Urinary system: cystitis, dysuria, hematuria, going to the bathroom alot, renal stones, urinary tract infection

Vision: blurred vision, cataract, conjunctivitis, eye pain

EL CELEBREX (CELECOXIB(: Laboratorio PFIZER)
---------------------------------------------------------------
EL CELEBREX (CELECOXIB) la otra droga del GRUPO DE LOS COXIBS TIENE en su haber mas de 90 EFECTOS ADVERSOS REPORTADOS ASOCIADOS A SU USO: entre ellos destacando el infarto al MIOCARDIO. 

Lo mas interesante de estas moleculas es un articulo publicado en el WALL STREET JOURNAL,y tambien publicado en el DIARIO EL NACIONAL EN NUESTRO PAIS, BAJO EL TITULO: UNA IRONIA, CURARSE DE UNA ARTRITIS PARA MORIR DEL CORAZON, donde se dice que el laboratorio ESCONDIO RESULTADOS de estudios donde quedaba en EVIDENCIA EL EFECTO PROTROMBOTICO Y LESIVO PARA EL CORAZON. 

El laboratorio PFIZER EN NUESTRO PAIS ESTABA ENTREGANDO PARA ESE AÑO UNA COMUNICACION DESCALIFICANDO EL ESTUDIO PUBLICADO EN EL JAMA, que fue el que DESTAPO LA CAÑERIA, de este MEDICAMENTO. Yo le dije al visitador MEDICO QUE ESE ERA UN ESTUDIO SERIO Y QUE ADEMAS EXISTIAN OTROS DONDE SE DEMOSTRABA QUE VIOXX Y CELEBREX tienen un EVIDENTE EFECTO PROTROMBOTICO.

PARA EL 30 DE SEPTIEMBRE del 2.004 EL VIOXX( ROFECOXIB), molecula casi hermana del CELEBREX (CELECOXIB) fue retirada del mercado por el mismo laboratorio MERCK demostrandose que los eventos cardiacos estaban realmente relacionados con el uso de esta molecula....

El Celebrex y sus 90 Efectos adversos:


PRINCIPALMENTE:

Riesgo de eventos cardiovasculares: Infarto al miocardio, angina inestable, trombo cardiaco, arresto cardiaco, muerte subita e inexplicable, choque isquemico, ataques isquemicos transitorios. 

OTROS EFECTOS ADVERSOS:

Presentados en 0.1 a 1.9% de pacientes:

GI- constipation, diverticulitis, gastritis, gastroenteritis, hemorrhoides, hiatal hernia, estomatitis, vomitos

CV - agravacion de alta presion arterial, boca seca, glaucoma

General: agravacion de alergiad, reaccion alergica, dolor en el pecho, inflamacion generalizada, inflamacion de la cara, fatiga, fiebre, aumento de temperatura subita, flu-like syndrome, dolor, dolor periferico

CNS, PNS- calambres en piernas, migraña, neuralgia, neuropatia, parestesia, vertigo.

aparato reproductivo femenino- fibroadenosis en mamas, neoplasmas en mamas, dolor en mamas, dismenorrea, desordenes menstrualesr, hemorragia vaginal, vaginitis

Aparato reproductor masculino- desordenes prostaticos.

Oido y vestibular: sordera,anormalidad en audicion, dolor de oido, tinitus.

Cardiovascular: angina pectoris, desordenes coronarios arterialesr, INFARTO AL MIOCARDIO, palpitacion, taquicardia

Higado y sistema biliar: anormal funcion hepatica

Metabolicos y nutritionales: Cambios en la funcion hepatica y renal, DM, elevacion del colesterol, aumento de azucar en sangre, disminucion del potasio, aumento de peso.

Musculoesqueleticos: Artralgia, artrosis, desordenes oseos, fracturas espontaneas, endirecimiento del cuello, dolor en ariculaciones, tendinitis.

Plaquetas: sangramiento nasal, bruising

Psiquiatricos: anorexia, ansiedad, aumento de apetito, depresion, nerviousismo, somnolencia

Hematologicos: anemia

Respiratorios: bronquitis, dificultad para respirar, agravacion de tos, disnea, laringitis, pneumonia.

Piel y apendices: perdidad de cabello, dermatitis, desordenes ungueales, sensibilidad a la luz, prurito, rash, piel seca, aumento de la sudoracion.

Sentidos: Alteracion del gusto.

Sistema urinario: cistitis, disuria, hematuria, aumentode la frecuencia urinaria, calculos renales, infeccion del tracto urinario.

Vision: vision borrosa, cataratas, conjuntivitis, dolor en ojos


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11.) THE ISOTRETINOIN (ACCUTANE-ROACCUATNE), Lab ROCHE).

THE ISOTRETINOIN, popular drug for the treatment of the acne in the market since 1.982. 

In the year of 1.999 for the first anniversary of the DERMAGIC publishes the TOPIC, the ISOTRETINOIN, THE GOOD, THE BAD AND THE UGLY, which I like a lot in the NET. 

In fact the Roche LABORATORY invites myself to a conference on THE ACCUTANE-ROACCUTANE (ISOTRETINOIN) that takes to effect in the HOTEL PIPO of Maracay through its medical VISITOR.

Today THREE YEARS LATER (December 2.002) for my own bill I will carry out An UPDATE on the adverse effects of THIS POPULAR DRUG, to ALERT TO the YOUNG PEOPLE of our country and the world who suffer of ACNE, the adverse effects that this pill takes place in its bodies, especially to those of the FEMININE sex, WHERE THE FDA RECENTLY APPROVED A RESOLUTION THAT to BE ABLE to TAKE THE MEDICINE, they should BE USING 2 (TWO),I REPEAT 2 (TWO) METHODS OF CONTRACEPTION at the same time to avoid a pregnancy, because if it takes place, the baby will COME WITH MALFORMATIONS!! 

EVEN, ALL PATIENT OF THE FEMININE SEX IN FERTILE AGE THAT ROACCUTANE will TAKE, ONLY was GIVEN TREATMENT BY one MONTH (30 DAYS) AND EVERY MONTH A TEST OF PREGNANCY will BE PRACTICED to SEE IF THE TREATMENT WILL be CONTINUED. This is a new denominated SMART PROGRAM that some months ago put on in practices in EEUU to avoid CONGENITAL MALFORMATIONS!!! 

I also invite the doctors OF THE UNIVERSE to INFORM APPROPRIATELY TO THE PATIENTS OF THE ADVERSE EFFECTS that the drug takes place, so that them based on its OWN APPROACH DECIDE to TAKE OR NOT THE MEDICINE, AND THE FEMALES to SIGN, I REPEAT to SIGN THE WRITTEN COMMITMENT THAT THE DOCTOR should PRESENT THEM BEFORE OF BEGINNING THE TREATMENT WITH ISOTRETINOIN, under a format that THE SAME LABORATORY DISTRIBUTES to THE DOCTORS. 

MAIN ADVERSE EFFECTS OF THE ISOTRETINOIN: 

(according to studies and reported cases)
==================================== 

1.) Xerosis Cutis, Dryness of the Skin. 
2.) Facial Erythema. 
3.) Arthralgia. 
4.) Dryness of lips. 
5.) Dryness of mucous nasal. 
6.) Muscular pain, I damage muscular and enzyme increase CPK. 
7.) Pemphigus. (skin)
8.) Cerebral Pseudotumor 
9.) Worsening of the ACNE. (skin) 
10.) Nasal bleeding. 
11.) Pyogenic Granuloma. 
12.) Hyperandrogenism in the woman 
13.) acne FULMINANS. 
14. ) Erythema Nodosum (Skin) 
15.) TERATOGENESIS in the pregnant woman: fetal malformations: HEARD, BRAIN, HEART, MENTAL RETARD, CRANIO-FACIAL ABNORMALITIES. 
16.) Ossification of ligaments 
17.) Bone alterations: DYSFUNCTIONS IN THE OSTEOGENESIS, hyperostosis, LOST OF THE BONE DENSITY. 
18.) Vasculitis (skin-blood vessels) 
19.) ocular alterations: Dryness of conjunctive, blurred vision, difficulty for the night vision. SOME NOT IRREVERSIBLE THEN OF CONCLUDED THE TREATMENT. 
20.) Alterations in the hair: curly hair, loss hair
21.) Increase of hepatic enzymes and sanguine lipids. 
22.) induction to the DEPRESSION AND SUICIDE: changes of mood and behavior. 
23.) Changes at sanguine level: FIBRINOLYSIS. 
24.) Miliaria crystallina (skin) 
25.) Alterations of the fingernails: Median canaliform dystrophy, paronychia
26.) RENAL alterations: Urethritis, renal impairment. 
27.) Inefficacy of the treatment.
28.) LUNG disease: Eosinophilic pneumonia.
29.) Alteration in steroid metabolism in women with acne. 
30.) Do not donate blood while taking this medicine or for 1 month after your last dose. Blood donated while taking isotretinoin may be given to a pregnant woman and be harmful to her baby.
31.) Allergic reaction: Itching or hives, swelling in face or hands, swelling or tingling in the mouth or throat, tightness in chest, trouble breathing 
32.) Hearing problems or ringing in the ears 
33.) diarrhea, nausea, or stomach pain 
34.) headache, dizziness, nausea, vomiting 
35.) Yellow skin or eyes 
36.) SEIZURES.

VERY PROBABLY EXIST MORE...

Patient with history of DIABETES, PSYCHOLOGICAL DYSFUNCTIONS, CARDIAC ILLNESS, ELEVATED LEVELS OF TRIGLYCERIDES AND CHOLESTEROL, ASTHMA, OSTEOPOROSIS, ANOREXIA NERVOSA AND LIVER DISEASE, they won't take isotretinoin or to take it in doses monitoring by the doctor who prescribe the drug. 

THE ISOTRETINOIN is A DRUG of DELICATE use, but that it has shown ITS BENEFITS IN THE SEVERE ACNE, but that HAS MANY ADVERSE EFFECTS mainly IN THE WOMAN IF become PREGNANT, and the YOUNG PEOPLE BEFORE OF COMPLETING THE TOTAL SKELETAL DEVELOPMENT they should KNOW THAT THIS DRUG can PRODUCE ALTERATIONS IN THE BONES. !!! 

IF you TAKE ISOTRETINOIN AND OBSERVES SOME ADVERSE EFFECT, CONSULT TO YOUR DOCTOR IMMEDIATELY!!! AND NOT TAKE DRUGS BY YOUR OWN DECISION !!! 

Maybe the adverse effect MORE FEARED OF THE ISOTRETINOIN are THE INDUCTION TO THE DEPRESSION AND THE SUICIDE, MORE OF 100 PEOPLE have DIED FOR THIS CAUSE IN THE WORLD.... a generic of this denominated DRUG exists in our country called ISOFACE, and the generic ones in the market of USA they are causing problems with the strict control that one has on the use of this drug in the women in reproductive age....

LA ISOTRETINOINA (ROACCUTANE-ACCUTANE) Laboratorio Roche

LA ISOTRETINOINA, popular droga para el tratamiento del acne, en el mercado desde 1.982.

En el año de 1.999 para el primer aniversario del DERMAGIC se publico el TEMA, la ISOTRETINOINA, LO BUENO, LO MALO Y LO FEO, la cual gusto mucho en la RED. 

De hecho el LABORATORIO ROCHE me invito a una conferencia sobre EL ACCUTANE-ROACCUTANE (ISOTRETINOINA) que se llevo a efecto en el HOTEL PIPO de Maracay a traves de su VISITADOR medico.

Hoy TRES AÑOS DESPUÉS (diciembre 2.002) por mi propia cuenta voy a realizar UNA ACTUALIZACION sobre los efectos adversos de ESTA POPULAR DROGA, para ALERTAR A los JOVENES de nuestro pais y el mundo, quienes padecen de ACNE, sobre los efectos adversos que esta pastilla produce en sus cuerpos, especialmente a las del sexo FEMENINO, DONDE LA FDA RECIENTEMENTE APROBO UNA RESOLUCIÓN QUE PARA PODER TOMAR LA MEDICINA, DEBEN ESTAR UTILIZANDO 2 (DOS), REPITO 2 (DOS) METODOS DE ANTICONCEPCIÓN al mismo tiempo para evitar un embarazo, pues de producirce, el NIÑO VENDRA CON MALFORMACIONES !! 

MAS AUN, TODA PACIENTE DEL SEXO FEMENINO EN EDAD FERTIL, QUE VAYA A TOMAR ROACCUTANE SOLO SE LE SUMINISTRARA TRATAMIENTO POR UN MES (30 DIAS) Y CADA MES DEBERA PRACTICARSE UN TEST DE EMBARAZO PARA VER SI SE CONTINUA CON EL TRATAMIENTO. Este es un nuevo PROGRAMA denominado SMART que hace unos meses se puso en practica en ESTADOS UNIDOS DE NORTEAMERICA para evitar MALFORMACIONES CONGENITAS !!! 

Invito tambien a los medicos DEL UNIVERSO A INFORMAR ADECUADAMENTE A LOS PACIENTES DE LOS EFECTOS ADVERSOS que la droga produce, para que estos en base a su PROPIO CRITERIO DECIDAN TOMAR O NO LA MEDICINA, Y LAS HEMBRAS FIRMAR, REPITO FIRMAR EL COMPROMISO ESCRITO QUE EL MEDICO DEBE PRESENTARLES ANTES DE INICIAR EL TRATAMIENTO CON ISOTRETINOIN, bajo un formato que EL MISMO LABORATORIO DISTRIBUYE A LOS MEDICOS. 

PRINCIPALES EFECTOS ADVERSOS DE LA ISOTRETINOINA, 
(según estudios y casos reportados) 
====================================== 
1.) Xerosis cutis, resequedad de la Piel. 
2.) Eritema (enrojeciemiento) 
3.) Artralgia (dolores articulares) 
4.) Resequedad de labios. 
5.) Resequedad de mucosa nasal 
6.) Dolores musculares, daño muscular y aumento de enzima CPK 
7.) Penfigo (piel) 
8.) Pseudotumor cerebral 
9.) Empeoramiento del ACNE. 
10.) Sangramiento nasal 
11.) Granuloma piogenico(Piel) 
12.) Hiperandrogenismo en la mujer 
13.) Acne FULMINANTE. 
14.) Eritema Nodoso (Piel) 
15.) TERATOGENESIS en la mujer embarazada: malformaciones fetales: OIDO, CEREBRO, CORAZON, RETARDO MENTAL, ANORMALIDADES CRANEO-FACIALES. 
16.) Osificacion de ligamentos 
17.) Alteraciones oseas: TRASTORNOS EN LA OSTEOGENESIS, hiperostosis, PERDIDA DE LA DENSIDAD OSEA. 
18.) Vasculitis (piel) 
19.) Alteraciones oculares: resequedad de conjuntiva, vision borrosa, dificultad para la vision nocturna. ALGUNAS NO IRREVERSIBLES LUEGO DE CONCLUIDO EL TRATAMIENTO. 
20.) Alteraciones en el cabello: cabello rizado, perdida del cabello 
21.) Aumento de enzimas hepaticas y lipidos sanguineos. 
22.) Induccion a la DEPRESION Y SUICIDIO: cambios de humor y conducta. 
23.) Cambios a nivel sanguineo: FIBRINOLISIS. 
24.) Miliaria cristalina (piel) 
25.) Alteraciones de las uñas: Distrofia mediana canaliforme, paroniquia. 
26.) Alteraciones RENALES: Uretritis, empeoramiento de funcion renal. 
27.) Ineficacia del tratamiento.
28.) Enfermedad pulmonar: neumonia eosinofilica
29.) Alteracion en el metabolismo esteroideo en la mujer con acne
30.) No puede donar SANGRE durante el tratamiento y hasta un mes despues de terminado el mismo. Donar sangre durante tratamiento con isotretinoina a una mujer embarazada puede resultar peligroso para el bebe.
31.) Reacción alérgica: Prurito y habones, inflamacion de la cara o manos, hinchazón u hormigueo en la boca o garganta, pesadez en el pecho, problemas respiratorios. 
32.) Problemas auditivos o campaneo en los oidos. 
33.) Diarrea, náusea, o dolor del estómago. 
34.) Dolor de cabeza, vértigo, náusea, vomitos. 
35.) piel amarilla u ojos. 
36.) CONVULSIONES.

MUY PROBABLEMENTE EXISTAN OTROS MAS...

Pacientes con historia de DIABETES, TRASTORNOS PSICOLOGICOS, ENFERMEDAD CARDIACA, TRIGLICERIDOS Y COLESTEROL ELEVADOS, ASMA, OSTEOPOROSIS, ANOREXIA NERVIOSA Y ENFERMEDAD HEPATICA no deberan tomar isotretinoin o tomarlo a dosis monitoreadas por el medico. 

EL ISOTRETINOIN ES UNA DROGA de uso DELICADO, pero que ha mostrado SUS BENEFICIOS EN EL ACNE SEVERO, pero que TIENE MUCHOS EFECTOS ADVERSOS SOBRE TODO EN LA MUJER SI SALE EMBARAZADA, y los JOVENES ANTES DE COMPLETAR EL DESARROLLO ESQUELETICO DEBEN SABER QUE ESTA DROGA PUEDE PRODUCIR ALTERACIONES EN LOS HUESOS. !!! 

SI USTED TOMA ISOTRETINOIN Y OBSERVA ALGUN EFECTO INDESEADO, CONSULTE A SU MEDICO INMEDIATAMENTE !!! Y NO SE AUTOMEDIQUE !!! 

Quiza el efecto adverso MAS TEMIDO DE LA ISOTRETINOINA ES LA INDUCCION A LA DEPRESION Y AL SUICIDIO, HAN MUERTO POR ESTA CAUSA MAS DE 100 PERSONAS EN EL MUNDO.... existe en nuestro pais un generico de esta DROGA denominado ISOFACE, y los genericos en el mercado de USA estan ocasionando problemas con el control estricto que se tiene sobre el uso de esta droga en las mujeres en edad reproductiva....

 
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12.) THE BEXTRA (VALDECOXIB), (Lab. PFIZER).

 

THE BEXTRA (VALDECOXIB), another molecules but representative of the the feared molecules COX-2, the same as ROFECOXIB,(VIOXX - already retired of the market), CELECOXIB, (CELEBREX), PARECOXIB (DYNASTAT) and the new clone that he comes over there from the same laboratory Merck (ARCOXIA)

To the BEXTRA, THERE you HAVE about 250 adverse effects attributed to her and the warnings of the FDA...

LA BEXTRA (VALDECOXIB) Laboratory PFIZER)
--------------------------------------------------------------

LA BEXTRA (VALDECOXIB), otra moleculas mas representante del las temidas moleculas COX-2, al igual que ROFECOXIB,(VIOXX- ya retirado del mercado), CELECOXIB, (CELEBREX), PARECOXIB (DYNASTAT) y el nuevo clon que viene por alli del mismo laboratorio Merck (ARCOXIA)

ALLI TIENEN unos 250 efectos adversos atribuidos a ella y las advertencias de la FDA.
LA BEXTRA FUE RETIRADA DEL MERCADO EL DIA 7 DE ABRIL DEL 2.005
====================================
THE BEXTRA (VALDECOXIB) SIDE EFFECTS
====================================
Source: Http://www.rxlist.com/

Of the patients treated with BEXTRA Tablets in controlled arthritis trials,2665 were patients with OA,and 2684 were patients with RA.More than 4000 patients have received a chronic total daily dose of BEXTRA 10 mg or more.More than 2800 patients have received BEXTRA 10 mg/day,or more,for at least 6 months and 988 of these have received BEXTRA for at least 1 year.

Osteoarthritis and Rheumatoid Arthritis

Table 4 lists all adverse events,regardless of causality,that occurred in ³ 2.0% of patients receiving BEXTRA 10 and 20mg/day in studies of three months or longer from 7 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

In these placebo- and active-controlled clinical trials, the discontinuation rate due to adverse events was 7.5% for arthritis patients receiving valdecoxib 10 mg daily, 7.9% for arthritis patients receiving valdecoxib 20 mg daily and 6.0% for patients receiving placebo.

In the seven controlled OA and RA studies, the following adverse events occurred in 0.1–1.9% of patients treated with BEXTRA 10 –20 mg daily, regardless of causality.

Application site disorders: Cellulitis, dermatitis contact

From Our Sponsors

Cardiovascular:Aggravated hypertension, aneurysm, anginapectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension

Central, peripheral nervous system: Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, pares-thesia, tremor, twitching, vertigo

Endocrine: Goiter

Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vaginal hemorrhage

Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroe-sophageal reflux, hematemesis, hematochezia, hemorrhoids, hemorrhoids bleeding, hiatal hernia, melena, stomatitis, stool frequency increased, tenesmus, tooth disorder, vomiting

General: Allergy aggravated, allergic reaction, asthenia, chest pain, chills, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, peripheral pain Hearing and vestibular: Ear abnormality, earache, tinnitus

Heart rate and rhythm: Bradycardia, palpitation, tachycardia

Hemic: Anemia

Liver and biliary system: Hepatic function abnormal, hepatitis, ALT increased, AST increased

Male reproductive: Impotence, prostatic disorder

Metabolic and nutritional: Alkaline phosphatase increased, BUN increased, CPK increased, creatinine increased, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, LDH increased, thirst increased, weight decrease, weight increase, xerophthalmia

Musculoskeletal: Arthralgia, fracture accidental, neck stiffness, osteoporosis, synovitis, tendonitis

Neoplasm: Breast neoplasm, lipoma, malignant ovarian cyst

Platelets (bleeding or clotting): Ecchymosis, epistaxis, hematoma NOS, thrombocytopenia

Psychiatric: Anorexia, anxiety, appetite increased, confusion, depression, depression aggravated, insomnia, nervousness, morbid dreaming, somnolence

Resistance mechanism disorders: Herpes simplex, herpes zoster, infection fungal,infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media

Respiratory: Abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, rhinitis

Skin and appendages: Acne, alopecia, dermatitis, dermatitis fungal, eczema, photosensitivity allergic reaction, pruritus, rash erythematous, rash maculopapular, rash psoriaform, skin dry, skin hypertrophy, skin ulceration, sweating increased, urticaria

Special senses: Taste perversion


Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, urinary tract infection

Vascular: Claudication intermittent, hemangioma acquired, varicose vein

Vision: Blurred vision, cataract, conjunctival hemorrhage, conjunctivitis, eye pain, keratitis, vision abnormal

White cell and RES disorders: Eosinophilia, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia

Other serious adverse events that were reported rarely (estimated <0.1%) in clinical trials, regardless of causality, in patients taking BEXTRA:

Autonomic nervous system disorders: Hypertensive encephalopathy, vasospasm

Cardiovascular: Abnormal ECG,aortic stenosis, atrial fibrillation, carotid stenosis, coronary thrombosis, heart block,heart valve disorders, mitral insufficiency, myocardial infarction, myocardial ischemia, pericarditis, syncope, thrombophlebitis, unstable angina, ventricular fibrillation

Central, peripheral nervous system: Convulsions

Endocrine: Hyperparathyroidism

Female reproductive: Cervical dysplasia

Gastrointestinal: Appendicitis, colitis with bleeding, dysphagia, esophageal perforation, gastrointestinal bleeding, ileus, intestinal obstruction, peritonitis

Hemic: Lymphoma-like disorder, pancytopenia

Liver and biliary system: Cholelithiasis

Metabolic: Dehydration

Musculoskeletal: Pathological fracture, osteomyelitis

Neoplasm: Benign brain neoplasm, bladder carcinoma, carcinoma, gastric carcinoma, prostate carcinoma, pulmonary carcinoma

Platelets (bleeding or clotting): Embolism, pulmonary embolism, thrombosis

Psychiatric: Manic reaction, psychosis

Renal: Acute renal failure

Resistance mechanism disorders: Sepsis

Respiratory: Apnea, pleural effusion, pulmonary edema, pulmonary fibrosis, pulmonary infarction, pulmonary hemorrhage, respiratory insufficiency

Skin: Basal cell carcinoma, malignant melanoma

Urinary system: Pyelonephritis, renal calculus

Vision: Retinal detachment

Postmarketing Experience

The following reactions have been identified during postmarketing use of BEXTRA. These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: Hypersensitivity reactions (including anaphylactic reactions and angioedema)

Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis


DRUG INTERACTIONS
The drug interaction studies with valdecoxib were performed both with valdecoxib and a rapidly hydrolyzed intravenous prodrug form. The results from trials using the intravenous prodrug are reported in this section as they relate to the role of valdecoxib in drug interactions.

General: In humans,valdecoxib metabolism is predominantly mediated via CYP 3A4 and 2C9 with glucuronidation being a further (20%) route of metabolism.In vitrostudies indicate that valdecoxib is a moderate inhibitor of CYP 2C19 (IC50 = 6 µg/mL),and a weak inhibitor of both 3A4 (IC50 = 44µg/mL) and 2C9 (IC50 = 13 µg/mL).In view of the limitations of in vitrostudies and the high valdecoxib IC50 values,the potential for such metabolic inhibitory effects in vivoat therapeutic doses of valdecoxib is low.

Aspirin: Concomitant administration of aspirin with valdecoxib may result in an increased risk of GI ulceration and complications compared to valdecoxib alone.Because of its lack of anti-platelet effect valdecoxib is not a substitute for aspirin for cardiovascular prophylaxis.

In a parallel group drug interaction study comparing the intravenous prodrug form of valdecoxib at 40 mg BID (n=10) vs placebo (n=9),valdecoxib had no effect on in vitroaspirin-mediated inhibition of arachidonate- or collagen-stimulated platelet aggregation.

Methotrexate: Valdecoxib 10 mg BID did not show a significant effect on the plasma exposure or renal clearance of methotrexate.

ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors.This interaction should be given consideration in patients taking BEXTRA concomitantly with ACE-inhibitors.

Furosemide: Clinical studies,as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients.This response has been attributed to inhibition of renal prostaglandin synthesis.

Anticonvulsants: Anticonvulsant drug interaction studies with val-decoxib have not been conducted.As with other drugs,routine monitoring should be performed when therapy with BEXTRA is either initiated or discontinued in patients on anticonvulsant therapy.

Dextromethorphan: Dextromethorphan is primarily metabolized by CYP 2D6 and to a lesser extent by 3A4.Coadministration with val-decoxib (40 mg BID for 7 days) resulted in a significant increase in dextromethorphan plasma levels suggesting that,at these doses,val-decoxib is a weak inhibitor of 2D6.Dextromethorphan plasma concentrations in the presence of high doses of valdecoxib were almost 5-fold lower than those seen in CYP 2D6 poor metabolizers.

Lithium: Valdecoxib 40 mg BID for 7 days produced significant decreases in lithium serum clearance (25%) and renal clearance (30%) with a 34% higher serum exposure compared to lithium alone. Lithium serum concentrations should be monitored closely when initiating or changing therapy with BEXTRA in patients receiving lithium.Lithium carbonate (450mg BID for 7 days) had no effect on valdecoxib pharmacokinetics.

Warfarin: The effect of valdecoxib on the anticoagulant effect of warfarin (1 – 8 mg/day) was studied in healthy subjects by coadminis-tration of BEXTRA 40 mg BID for 7 days.Valdecoxib caused a statistically significant increase in plasma exposures of R-warfarin and S-warfarin (12% and 15%,respectively),and in the pharmacodynamic effects (prothrombin time,measured as INR) of warfarin.While mean INR values were only slightly increased with coadministration of valdecoxib,the day-to-day variability in individual INR values was increased.Anticoagulant therapy should be monitored,particularly during the first few weeks,after initiating therapy with BEXTRA in patients receiving warfarin or similar agents.

Fluconazole and Ketoconazole: Ketoconazole and fluconazole are predominantly CYP 3A4 and 2C9 inhibitors, respectively. Concomitant single dose administration of valdecoxib 20 mg with multiple doses of ketoconazole and fluconazole produced a significant increase in exposure of valdecoxib.Plasma exposure (AUC) to valdecoxib was increased 62% when coadministered with flucona-zole and 38% when coadministered with ketoconazole.

Glyburide: Glyburide is a CYP 3A4 substrate.Coadministration of valdecoxib (10 mg BID for 7 days) with glyburide (5 mg QD or 10 mg BID) did not affect the pharmacokinetics (exposure) of glyburide.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Valdecoxib was not carcinogenic in rats given oral doses up to 7.5mg/kg/day for males and 1.5mg/kg/day for females (equivalent to approximately 2- to 6-fold human exposure at 20 mg QD as measured by the AUC(0-24hr)) or in mice given oral doses up to 25mg/kg/day for males and 50mg/kg/day for females (equivalent to approximately 0.6- to 2.4-fold human exposure at 20 mg QD as measured by the AUC(0-24hr)) for two years..

Valdecoxib was not mutagenic in an Ames test or a mutation assay in Chinese hamster ovary (CHO) cells,nor was it clastogenic in a chromosome aberration assay in CHO cells or in an in vivomicronucleus test in rat bone marrow.

Valdecoxib did not impair male rat fertility at oral doses up to 9.0mg/kg/day (equivalent to approximately 3- to 6-fold human exposure at 20 mg QD as measured by the AUC (0-24hr)).In female rats,a decrease in ovulation with increased pre- and post-implantation loss resulted in decreased live embryos/fetuses at doses ³ 2 mg/kg/day (equivalent to approximately 2-fold human exposure at 20mg QD as measured by the AUC (0-24hr) for valdecoxib).The effects on female fertility were reversible.This effect is expected with inhibition of prostaglandin synthesis and is not the result of irreversible alteration of female reproductive function.

Pregnancy

Teratogenic Effects: Pregnancy Category C.

The incidence of fetuses with skeletal anomalies such as semi-bipartite thoracic vertebra centra and fused sternebrae was slightly higher in rabbits at an oral dose of 40 mg/kg/day (equivalent to approximately 72-fold human exposures at 20mg QD as measured by the AUC(0-24hr)) throughout organogenesis.Valdecoxib was not teratogenic in rabbits up to an oral dose of 10 mg/kg/day (equivalent to approximately 8-fold human exposures at 20 mg QD as measured by the AUC(0-24hr)).

Valdecoxib was not teratogenic in rats up to an oral dose of 10mg/kg/day (equivalent to approximately 19-fold human exposure at 20 mg QD as measured by the AUC (0-24hr)).There are no studies in pregnant women.However,valdecoxib crosses the placenta in rats and rabbits.BEXTRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Non-teratogenic Effects: Valdecoxib caused increased pre-and post-implantation loss with reduced live fetuses at oral doses

³ 10mg/kg/day (equivalent to approximately 19-fold human exposure at 20 mg QD as measured by the AUC (0-24hr)) in rats and an oral dose of 40 mg/kg/day (equivalent to approximately 72-fold human exposure at 20 mg QD as measured by the AUC (0-24hr)) in rabbits throughout organogenesis.In addition,reduced neonatal survival and decreased neonatal body weight when rats were treated with valdecoxib at oral doses ³ 6 mg/kg/day (equivalent to approximately 7-fold human exposure at 20 mg QD as measured by the AUC(0-24hr)) throughout organogenesis and lactation period.No studies have been conducted to evaluate the effect of valdecoxib on the closure of the ductus arteriosus in humans.Therefore,as with other drugs known to inhibit prostaglandin synthesis,use of BEXTRA during the third trimester of pregnancy should be avoided.

Labor and Delivery

Valdecoxib produced no evidence of delayed labor or parturition at oral doses up to 10 mg/kg/day in rats (equivalent to approximately 19-fold human exposure at 20 mg QD as measured by the AUC (0-24hr)). The effects of BEXTRA on labor and delivery in pregnant women are unknown.

Nursing Mothers

Valdecoxib and its active metabolite are excreted in the milk of lactating rats.It is not known whether this drug is excreted in human milk.Because many drugs are excreted in human milk,and because of the potential for adverse reactions in nursing infants from BEXTRA,a decision should be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother and the importance of nursing to the infant.

Pediatric Use

Safety and effectiveness of BEXTRA in pediatric patients below the age of 18 years have not been evaluated.

Geriatric Use

Of the patients who received BEXTRA in arthritis clinical trials of three months duration,or greater,approximately 2100 were 65 years of age or older,including 570 patients who were 75 years or older.No overall differences in effectiveness were observed between these patients and younger patients.
=================================
New Warnings for Bextra (VALDECOXIB).
==================================

Source: Http://www.fda.gov/
The FDA and Pharmacia Corporation are advising health-care professionals about new warnings and information in the product labeling of Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and menstrual pain (dysmenorrhea). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects, including serious allergic reactions (anaphylactoid reactions). As these reactions can be life-threatening, people who start Bextra and experience a rash should discontinue the drug immediately. In addition, the labeling will state that the drug is contraindicated--not to be used--in patients allergic to sulfa-containing products.

Health-care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation, Peapack, N.J. at 1-800-323-4204 or to the FDA MedWatch program at 1-800-FDA-1088.

THE BEXTRA WAS RETIRED OF THE MARKET IN APRIL 7 OF THE 2005
===========================================
Valdecoxib-induced toxic epidermal necrolysis in a patient allergic to sulfa drugs.
===========================================
Pharmacotherapy. 2003 Apr; 23(4): 551-3.

Glasser DL, Burroughs SH.

Department of Pharmacy Practice, Bernard J. Dunn School of Pharmacy, Shenandoah University, 1460 University Drive, Winchester, VA 22601, USA. [email protected]

A 55-year-old Caucasian woman with a previously documented sulfa allergy was admitted to the hospital after she developed toxic epidermal necrolysis; she had been taking valdecoxib for 8 days for knee pain. Four days later, her bullous lesions had progressed to 45-50% of her body surface area. She was transferred to a burn unit for aggressive wound care and fluid hydration. Valdecoxib, a cyclooxygenase-2 inhibitor, is a benzenesulfonamide prescribed for arthritis pain and inflammation, and dysmenorrhea. Clinicians should exercise caution when prescribing valdecoxib to patients who are allergic to sulfa drugs.
 

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DATA-MEDICOS/DERMAGIC-EXPRESS /OCTOBER JOURNAL 2.004-05/ DR. JOSE LAPENTA R. 
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Produced by Dr. Jose Lapenta R. Dermatologist 
Maracay Estado Aragua Venezuela 2.004-2.005  
    Tlf: 0416-6401045- 02432327287-024232328571