Cuenta Regresiva para las moleculas COX-2  !!!

Data-Medicos 
Dermagic/Express No.7-(X-12) 
04 Octube 2.005 /04 October 2.005 

EDITORIAL ESPAÑOL                                                  
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Hace 4 años inicie mi propia batalla contra estas moleculas (COX-2) las cuales desde un comienzo dije que eran malas, peligrosas para la salud, y nadie me hizo caso.
Hoy 4 años despues puedo decir que una vez mas el DERMAGIC, jamas se equivoco UNICO EN EL MUNDO ENTERO que hizo esta prediccion con 4 años de anticipacion.


1.) VIOXX (ROFECOXIB) fuera del mercado
2.) BEXTRA (VALDECOXIB) fuera del mercado
3.) AULIN, SCAFLAN, AINEX (NIMESULIDE) pediatrico fuera del mercado y el de adultos con altas restricciones, prohibido en numerosos paises)
4.) CELEBREX (CELECOXIB) aun en el mercado y con grandes problemas,
5.) PARECOXIB (DYNASTAT) comprobado tambien su efecto cardiotoxico)

Una vez mas el dermagic tenia la razon,
De estas moleculas algunas siguen en el mercado y vienen por alli unas nuevas COX-2,

Si tu quieres tomalas a largo plazo y si te mueres como un @@@·#### por no hacer caso
cuando llegues al cielos no digas, ohhh porque no lei antes el Dermagic Express !!!

Saludos a todos,,, alli les dejo unas perlas.

Dr. Jose Lapenta R


ENGLISH EDITORIAL
================
It has begun my own battle against these molecules for 4 years (COX-2) which I said from a beginning that they were bad, dangerous for the health, and nobody paid me attention.
Today 4 years later I can say that once the DERMAGIC, never mistakes, ONLY IN THE WHOLE WORLD that he made this prediction with 4 years of anticipation.


1.) VIOXX (ROFECOXIB) outside of the market
2.) BEXTRA (VALDECOXIB) outside of the market
3.) AULIN, SCAFLAN, AINEX (NIMESULIDE) pediatric outside of the market and that of adults with high restrictions, prohibited in numerous countries)
4.) CELEBREX (CELECOXIB) even in the market and with big problems,
5.) PARECOXIB (DYNASTAT) also checked their bad effect on the heart)

Once more time the dermagic had the reason,
Of these molecules, some continue in the market and they come some new COX-2 over there.

If you you want you take them long term and you die as an @ @ @· #### for not paying attention, when you reach the heaven don' t say, ohh why I don' t read the The Dermagic Express before !!!
 
Greetings to all,, some pearls i left today

                                                         HOT LINK

1.) Risk of cardiovascular events associated with selective COX-2 inhibitors.

Risk of cardiovascular events associated with selective COX-2 inhibitors.
 JAMA. 2001 Aug 22-29;286(8):954-9. Related Articles, Links

Comment in:
ACP J Club. 2002 Mar-Apr;136(2):53.
Curr Gastroenterol Rep. 2002 Dec;4(6):445.
JAMA. 2001 Dec 12;286(22):2808; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2809-10; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2809; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2809; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2810-1; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2810; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2810; author reply 2811-2.
JAMA. 2001 Dec 12;286(22):2811-2.

Summary for patients in:
Can Fam Physician. 2002 Sep;48:1449-51.

Mukherjee D, Nissen SE, Topol EJ.

Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, F 25, 9500 Euclid Ave, Cleveland, OH 44195, USA.

Atherosclerosis is a process with inflammatory features and selective cyclooxygenase 2 (COX-2) inhibitors may potentially have antiatherogenic effects by virtue of inhibiting inflammation. However, by decreasing vasodilatory and antiaggregatory prostacyclin production, COX-2 antagonists may lead to increased prothrombotic activity. To define the cardiovascular effects of COX-2 inhibitors when used for arthritis and musculoskeletal pain in patients without coronary artery disease, we performed a MEDLINE search to identify all English-language articles on use of COX-2 inhibitors published between 1998 and February 2001. We also reviewed relevant submissions to the US Food and Drug Administration by pharmaceutical companies. Our search yielded 2 major randomized trials, the Vioxx Gastrointestinal Outcomes Research Study (VIGOR; 8076 patients) and the Celecoxib Long-term Arthritis Safety Study (CLASS; 8059 patients), as well as 2 smaller trials with approximately 1000 patients each. The results from VIGOR showed that the relative risk of developing a confirmed adjudicated thrombotic cardiovascular event (myocardial infarction, unstable angina, cardiac thrombus, resuscitated cardiac arrest, sudden or unexplained death, ischemic stroke, and transient ischemic attacks) with rofecoxib treatment compared with naproxen was 2.38 (95% confidence interval, 1.39-4.00; P =.002). There was no significant difference in cardiovascular event (myocardial infarction, stroke, and death) rates between celecoxib and nonsteroidal anti-inflammatory agents in CLASS. The annualized myocardial infarction rates for COX-2 inhibitors in both VIGOR and CLASS were significantly higher than that in the placebo group of a recent meta-analysis of 23 407 patients in primary prevention trials (0.52%): 0.74% with rofecoxib (P =.04 compared with the placebo group of the meta-analysis) and 0.80% with celecoxib (P =.02 compared with the placebo group of the meta-analysis). The available data raise a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors. Further prospective trial evaluation may characterize and determine the magnitude of the risk.

2.) Merck Loses Suit: Must Pay Widow $253.4 Million In Vioxx Case .

Robert Ernst's Widow awarded $253.4 Million

 
Merck Loses Suit: Must Pay Widow $253.4 Million In Vioxx Case
Bob Perreault
Friday, August 19, 2005 4:38 PM

A Texas jury has found pharmaceutical giant Merck & Co. liable for the death of a man who took the once-popular painkiller Vioxx in the first of thousands of lawsuits pending across the country.

Merck has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits.

Jurors awarded Robert Ernst's widow, Carol, $253.4 million. She told CNBC that if she and her husband had known the risks associated with the drug, Robert never would have taken it.

Ernst was a tri-athlete.

Mark Lanier, Ernst family lawyer says it sets a precedent for Merck, which is facing thousands of other suits associated with the drug. He said that there would surely be higher payouts for victims.

The money awarded is a combination of his lost pay as a Wal-Mart produce manager, mental anguish, loss of companionship and punitive damages.

Merck shares dropped $2.36 on the day in New York to finish at $28.05.

 

3.) Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery.
 

N Engl J Med. 2005 Mar 17;352(11):1081-91. Epub 2005 Feb 15.

Comment in:
N Engl J Med. 2005 Mar 17;352(11):1131-2.
N Engl J Med. 2005 Mar 17;352(11):1133-5.


Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, Boyce SW, Verburg KM.

Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, TX 77225-0345, USA. [email protected]

BACKGROUND: Valdecoxib and its intravenous prodrug parecoxib are used to treat postoperative pain but may involve risk after coronary-artery bypass grafting (CABG). We conducted a randomized trial to assess the safety of these drugs after CABG. METHODS: In this randomized, double-blind study involving 10 days of treatment and 30 days of follow-up, 1671 patients were randomly assigned to receive intravenous parecoxib for at least 3 days, followed by oral valdecoxib through day 10; intravenous placebo followed by oral valdecoxib; or placebo for 10 days. All patients had access to standard opioid medications. The primary end point was the frequency of predefined adverse events, including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications. RESULTS: As compared with the group given placebo alone, both the group given parecoxib and valdecoxib and the group given placebo and valdecoxib had a higher proportion of patients with at least one confirmed adverse event (7.4 percent in each of these two groups vs. 4.0 percent in the placebo group; risk ratio for each comparison, 1.9; 95 percent confidence interval, 1.1 to 3.2; P=0.02 for each comparison with the placebo group). In particular, cardiovascular events (including myocardial infarction, cardiac arrest, stroke, and pulmonary embolism) were more frequent among the patients given parecoxib and valdecoxib than among those given placebo (2.0 percent vs. 0.5 percent; risk ratio, 3.7; 95 percent confidence interval, 1.0 to 13.5; P=0.03). CONCLUSIONS: The use of parecoxib and valdecoxib after CABG was associated with an increased incidence of cardiovascular events, arousing serious concern about the use of these drugs in such circumstances. Copyright 2005 Massachusetts Medical Society.


4.) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention.
 

N Engl J Med. 2005 Mar 17;352(11):1071-80. Epub 2005 Feb 15.


Comment in:
ACP J Club. 2005 Jul-Aug;143(1):3.
N Engl J Med. 2005 Jun 23;352(25):2648-50; author reply 2648-50.
N Engl J Med. 2005 Mar 17;352(11):1131-2.
N Engl J Med. 2005 Mar 17;352(11):1133-5.

Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M; Adenoma Prevention with Celecoxib (APC) Study Investigators.

Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. [email protected]

BACKGROUND: Selective cyclooxygenase-2 (COX-2) inhibitors have come under scrutiny because of reports suggesting an increased cardiovascular risk associated with their use. Experimental research suggesting that these drugs may contribute to a prothrombotic state provides support for this concern. METHODS: We reviewed all potentially serious cardiovascular events among 2035 patients with a history of colorectal neoplasia who were enrolled in a trial comparing two doses of celecoxib (200 mg or 400 mg twice daily) with placebo for the prevention of colorectal adenomas. All deaths were categorized as cardiovascular or noncardiovascular, and nonfatal cardiovascular events were categorized in a blinded fashion according to a prespecified scheme. RESULTS: For all patients except those who died, 2.8 to 3.1 years of follow-up data were available. A composite cardiovascular end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure was reached in 7 of 679 patients in the placebo group (1.0 percent), as compared with 16 of 685 patients receiving 200 mg of celecoxib twice daily (2.3 percent; hazard ratio, 2.3; 95 percent confidence interval, 0.9 to 5.5) and with 23 of 671 patients receiving 400 mg of celecoxib twice daily (3.4 percent; hazard ratio, 3.4; 95 percent confidence interval, 1.4 to 7.8). Similar trends were observed for other composite end points. On the basis of these observations, the data and safety monitoring board recommended early discontinuation of the study drug. CONCLUSIONS: Celecoxib use was associated with a dose-related increase in the composite end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure. In light of recent reports of cardiovascular harm associated with treatment with other agents in this class, these data provide further evidence that the use of COX-2 inhibitors may increase the risk of serious cardiovascular events. Copyright 2005 Massachusetts Medical Society.




5.) Celecoxib-induced methemoglobinemia.

Celecoxib-induced methemoglobinemia.

Ann Pharmacother. 2004 Oct;38(10):1635-8. Epub 2004 Aug 24

Kaushik P, Zuckerman SJ, Campo NJ, Banda VR, Hayes SD, Kaushik R.

Department of Internal Medicine, Hospital Medicine Group, Baton Rouge General Medical Center, Baton Rouge, LA, USA. [email protected]

OBJECTIVE: To report a case of acute methemoglobinemia in a patient treated with celecoxib for osteoarthritis. CASE SUMMARY: A 72-year-old African American man developed an acute confusional state (ACS) one month after receiving celecoxib for osteoarthritis of his knee joints. There was no other identifiable cause of ACS such as any recognized cause of metabolic encephalopathy, meningoencephalitis, cerebrovascular accident, or drug intoxication. He was found to have severe methemoglobinemia (serum methemoglobin fraction 9%; reference range 0-0.2). His symptoms improved substantially, and serum methemoglobin levels decreased to 0.7% after the initiation of methylene blue therapy. He was discharged on oral riboflavin and ascorbic acid and was advised not to restart celecoxib therapy. He had not shown any recurrence of the symptoms at a follow-up visit 2 months after the withdrawal of celecoxib. DISCUSSION: Celecoxib is a nonsteroidal antiinflammatory drug that selectively inhibits cyclooxygenase-2. Acute methemoglobinemia can present as a syndrome of nonspecific symptoms such as headache, nausea, fatigue, dyspnea, and lethargy; these may progress to respiratory depression, coma, shock, seizures, and death. Although acute methemoglobinemia has been reported with the use of several drugs, including sulfonamides, as of August 13, 2004, this is the first case report of severe methemoglobinemia manifesting as ACS with celecoxib therapy. Use of the Naranjo probability scale indicated a probable relationship between the clinical manifestations of methemoglobinemia and celecoxib therapy in this patient. CONCLUSIONS: Celecoxib can be associated with acute methemoglobinemia. Prompt diagnosis of this condition, withdrawal of celecoxib, and treatment with the antagonists (methylene blue, ascorbic acid, riboflavin) can reverse this potentially serious condition.

 

6.) Anaphylaxis to celecoxib.

Ann Allergy Asthma Immunol. 2001 Jul;87(1):72-3.

Levy MB, Fink JN.

Department of Pediatrics and Medicine, Medical College of Wisconsin, Milwaukee 53201, USA. [email protected]

BACKGROUND: Adverse reactions such as urticaria, angioedema, asthma, and anaphylaxis are known to be associated with nonsteroidal anti-inflammatory agents (NSAIDs). Celecoxib (Pfizer/Searle, Caguas, PR) is a new NSAID that differs in structure and mechanism of action of other similar drugs of this class. OBJECTIVE: Evaluation of a case of anaphylaxis to celecoxib (Celebrex). METHODS AND RESULTS: This report describes a 55-year-old woman who experienced the acute onset of pruritus, urticaria, respiratory distress, and hypotension minutes after ingesting a celecoxib capsule. She had taken the drug a previous time for tendonitis without difficulty. Treatment with epinephrine, corticosteroids, and intravenous fluids was successful. An IgE mechanism could not be detected. She has avoided the drug and has had no further problems. CONCLUSIONS: This is the first patient report of anaphylaxis attributable to celecoxib, a new NSAID. This suggests that physicians and other health care professionals should be aware of the potential serious side effects of this drug.

 

7.) Renal failure associated with the use of celecoxib and rofecoxib.

Drug Saf. 2002;25(7):537-44.

Ahmad SR, Kortepeter C, Brinker A, Chen M, Beitz J.

Division of Drug Risk Evaluation, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA. [email protected]

OBJECTIVE: Celecoxib and rofecoxib are two relatively new nonsteroidal anti-inflammatory drugs (NSAIDs) that selectively inhibit the cyclo-oxygenase-2 (COX-2) isoenzyme at therapeutic concentrations. The nephrotoxic potential of selective COX-2 inhibitors has not been clearly established. This study was conducted in order to understand the association between acute renal failure and the two COX-2 inhibitors celecoxib and rofecoxib. METHODS: A search was performed in the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) to identify cases of renal failure submitted to the FDA. A MEDLINE search of the English language literature was also performed to identify published cases of renal failure associated with celecoxib and rofecoxib. RESULTS: One hundred twenty-two and 142 domestic US cases of celecoxib and rofecoxib-associated renal failure, respectively, were identified in the AERS database. The literature search identified 19 cases of acute renal impairment in association with celecoxib and rofecoxib. In addition, drug regulatory authorities in the UK, Canada, and Australia have received about 50 reports of renal failure with celecoxib and rofecoxib. Descriptive statistics of the AERS cases have been summarised in this report. CONCLUSIONS: Data from AERS and published case reports suggest that use of both these drugs is associated with renal effects similar to that of conventional nonselective NSAIDs. Physicians should be aware that serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short-term therapy with celecoxib and rofecoxib. Patients at greatest risk for renal injury are those with pre-existing renal impairment, heart failure, liver dysfunction, those taking diuretics and/or ACE inhibitors, and the elderly. Kidney function should be monitored closely for any signs of potential renal injuries soon after initiating treatment with these agents, especially in high-risk populations. In addition, healthcare practitioners should adequately warn patients of the signs and symptoms of serious renal toxicity, and of the need for them to see their physician promptly if they occur. Celecoxib and rofecoxib are not recommended for use in patients with advanced renal disease.

 

8.) FDA advisory on Bextra withdrawal, Celebrex and other NSAIDs

Source: http://www.spine-health.com/

FDA information on Bextra and Celebrex

After several months of discussion and an Advisory Committee meeting, the Food and Drug Administration (FDA) announced its recommendation, on Thursday, April 7, 2005, that Bextra (valdecoxib) should be taken off the market. Bextra, a COX-2 inhibitor commonly used for arthritis and back pain, is manufactured by Pfizer, Inc. The voluntary withdrawal is based on the FDA’s decision that the risk/benefit analysis of Bextra is unfavorable. Pfizer has said it will suspend sales and marketing of Bextra pending further discussions with the FDA.

Bextra’s label was recently changed to include warnings for a potentially fatal skin disease. Combined with the risk of cardiovascular problems (i.e. heart attack and stroke), the FDA determined that the serious risks associated with Bextra are not outweighed by the anti-inflammatory and other benefits for arthritis and back pain patients.

The FDA also stated that Celebrex should remain on the market, but with stronger label warnings about the increased risk of heart attack and stroke. Given the voluntary recall of Vioxx in October 2004 and Bextra in April 2005, the only COX-2 inhibitor brand available in the U.S. is now Celebrex.

All prescription-strength NSAIDs (including Celebrex) will now display “black box” label warnings for the potential risk of cardiovascular events and gastrointestinal bleeding. Celebrex and other prescription NSAIDs are also asked to now include a Medication Guide to help educate patients on the cardiovascular and gastrointestinal side effects associated with the drugs. The FDA also requested that over-the-counter NSAIDs (such as ibuprofen, naproxen) include more information about the potential gastrointestinal and cardiovascular adverse side effects of the drugs, a warning about potential skin reactions, as well as information about safe use of the drugs (such as duration and dosage) (1).

FDA advisory process for COX-2 inhibitors
The Food and Drug Administration (FDA) held a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Arthritis Advisory Committee from February 16 to 18, 2005 regarding the benefits and health risks of non-steroidal anti-inflammatory drugs (NSAIDs). The committee included 32 panelists: 8 rheumatologists, 19 physicians, 8 epidemiologists and biostatisticians, 1 ethicist and several patient and industry representatives (2).

The FDA committee that convened in February discussed the risks and outcomes and possible restrictions for specific COX-2 inhibitor and other NSAID brands. While committee members agreed on warnings and restrictions for COX-2 inhibitors as a class of drugs, there was much less agreement on this information for each specific drug - indicating less confidence in the data at the individual drug level. Historically, the FDA has followed the recommendations of its advisory committees. However, given the close votes on specific COX-2 inhibitors, the call for further studies and the fact that no formal report was issued, it is perhaps not surprising that the FDA broke the trend this time and made some decisions that contradict the committee recommendations.

The Advisory Committee that convened in February issued a vote on specific COX-2 inhibitor brands (Celebrex, Bextra and Vioxx) and also on naproxen, another type of NSAID. The results of the committee’s votes were as follows:

COX-2 inhibitors:

Bextra (valdecoxib): The February committee on NSAIDs voted narrowly in favor of keeping Bextra on the market (17 “yes”, 13 “no”, 2 abstained) (2). This vote indicated a lower amount of confidence with Bextra than with other COX-2 inhibitors. In April 2005, the FDA decided request that Pfizer voluntarily withdraw Bextra from the market, and Pfizer has complied with this request.

Celebrex (celecoxib): The committee voted unanimously in favor of keeping Celebrex on the market, indicating greater confidence of the risk versus benefit analysis for the drug (2). Patients are encouraged to talk with their doctor about the risks and benefits of using Celebrex or any NSAID. They are also advised to use only the lowest effective dose for the shortest duration possible.

Vioxx (rofecoxib): The vote on Vioxx was a close 17 “yes” and 15 “no” to return Vioxx to the market since its withdrawal in September 2004. However, the final decision for whether or not Vioxx becomes available again will be determined by the FDA and Merck, the drug’s manufacturer. Merck has announced that it will petition the FDA for reintroduction of Vioxx, but it is not yet known whether studies will show significant new safety information.
Other NSAIDs:

Naproxen: Experts on the FDA panel raised the issue that the warnings for naproxen (brands include Aleve and Naprosyn) may have been exaggerated and needlessly frightened naproxen users. Some research shows that although naproxen poses some risk for heart attack, it may carry a lower risk than COX-2 inhibitors (2). However, more research testing naproxen against a placebo is necessary. As with all other NSAIDs, the FDA has recommended that naproxen will now carry stronger warnings for adverse side effects.
More research needed on NSAIDs
Additionalinformation is still needed to clearly determine health risks (versus benefits) based on duration of usage and dosages for specific brands of COX-2 inhibitors and NSAIDs. Further research is especially necessary to evaluate specific brands, as not all NSAIDs carry the same risk for heart problems. Based on currently available data, however, some degree of increased risk may be a class effect for all NSAIDs. The FDA Advisory Committee voted in favor of mandating cardiovascular safety studies as a condition for allowing COX-2 inhibitors and older NSAIDs to remain on or enter the market.

Patients should consult a physician to weigh their individual risks and benefits
The FDA advises patients who are or were taking Bextra to discontinue use of the drug and consult their physician. In determining a new treatment option, there is no single course of treatment using COX-2 inhibitors and other NSAIDs that will be optimal for all patients. For patients taking any type of NSAIDs, it remains vital for patients to consult their physician and determine the safest treatment options.

The potential for adverse affects from NSAIDs is thought to increase for high-risk patients (i.e. those with a high risk for heart attack, stroke, recent recipients of heart bypass surgery, and patients with a high risk for gastrointestinal bleeding), as well as with higher dosage and with longer duration of usage. For guidelines for taking NSAIDs and explanation of the FDA’s Public Health Advisory on NSAIDs, please see Safe use of COX-2 inhibitors and other NSAIDs.

As more information becomes available, patients should not hesitate to consult their physician to re-evaluate their treatment options and to weigh their individual risks versus the benefits of Celebrex and other NSAIDs.

By: Doug Hendricks, MD
May 16, 2005

References:

U.S. Food and Drug Administration. FDA News. “FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).” April 7, 2005. http://www.fda.gov/bbs/topics/news/2005/NEW01171.html.

Cush JJ, Kavanaugh A, Matteson EL. “Hotline: American College of Rheumatology. Hotline: The Safety of COX-2 Inhibitors: Deliberations from the February 16-18, 2005, FDA Meeting.” American College of Rheumatology. http://www.rheumatology.org/publications/hotline/0305NSAIDs.asp

U.S. Food and Drug Administration. Questions and Answers “FDA Regulatory Actions for the Cox-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). http://www.fda.gov/cder/drug/infopage/COX2/COX2qa.htm

9.) GENERAL DISCUSION FORUM about CELECOXIB (CELEBREX)

Source: http://lp.finlaw.com/

celebrex law suit

I had a Heart attack,I am now in CHF and I also had some major stomach problems. I took celebrex for four year. Can you help me?
 

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DATA-MEDICOS/DERMAGIC-EXPRESS No 7-(X-12)  04/10/2.005 DR. JOSE LAPENTA R. 
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