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JULIO 2.004
JULY 2.004
NIMESULIDE(AULIN), PARECOXIB (DYNASTAT), BEXTRA (VALDECOXIB), XELODA (CAPECITABINE),
REMINYL(GALANTAMINE), ISOTRETINOIN,(ROACCUTANE, ACCUTANE, ISOFACE)
1.) Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents.
2.) Nimesulide-induced severe hemolytic anemia and acute liver failure leading to liver transplantation.
3.) REMINYL® (Galantamine) Reduces Rate of Alzheimer's Disease Progression By More Than 50 Percent Over Four Years of Therapy.
4.) Drugs Approved by the FDA/ Drug Name: Reminyl (galantamine hydrobromide).
5.) Xeloda® Improves Recurrence-Free Survival over 5-Fluorouracil/Leucovorin in Metastatic Colorectal Cancer.
6.) VALDECOXIB (bextra) Y PARECOXIB SODICO
(Dynastat): SEVERAS REACCIONES CUTANEAS Y DE HIPERSENSIBILIDAD.
7.) DYNASTAT® / Parecoxib.
8.) Parecoxib: new preparation: no proven advantage.
9.) Bextra /Bextra attracts the spotlight for blatant commercial use of academic journals.
10.) Prolonged thrombocytopenia associated with isotretinoin.
1.)
Upper gastrointestinal bleeding associated with the use of NSAIDs: newer
versus older agents.
Drug Saf. 2004;27(6):411-20.
Laporte JR, Ibanez L, Vidal X, Vendrell L, Leone R.
Department of Pharmacology, Therapeutics and Toxicology, Universitat Autonoma de
Barcelona, Barcelona, Spain. [email protected]
AIM: The relative gastrointestinal toxicity of NSAIDs in normal clinical
practice is unknown. The aim of this study was to estimate the risk of upper
gastrointestinal bleeding associated with NSAIDs and analgesics, with special
emphasis on those agents that have been introduced in recent years. DESIGN:
Multicentre case-control study. PATIENTS: All incident community cases of upper
gastrointestinal bleeding from a gastric or duodenal lesion in patients aged >18
years of age (4309 cases). After secondary exclusions, 2813 cases and 7193
matched controls were included in the analysis. SETTING: Eighteen hospitals in
Spain and Italy with a total study experience of 10,734,897 person-years. MAIN
OUTCOME MEASURE: Odds ratios of upper gastrointestinal bleeding for each drug,
with adjustment for potential confounders. For each individual drug the
reference category was defined as those not exposed to the drug. RESULTS: The
incidence of upper gastrointestinal bleeding was 401.4 per million inhabitants
aged >18 years. Thirty-eight percent of cases were attributable to NSAIDs.
Individual risks for each NSAID were dose dependent. Ketorolac was associated
with the highest risk estimate (24.7; 95% CI 8.0, 77.0). For newer NSAIDs, the
risks were as follows: aceclofenac 1.4 (95% CI 0.6, 3.3), celecoxib 0.3 (95% CI
0.03, 4.1), dexketoprofen 4.9 (95% CI 1.7, 13.9), meloxicam 5.7 (95% CI 2.2,
15.0), nimesulide 3.2 (95% CI 1.9, 5.6) and rofecoxib 7.2 (95% CI 2.3, 23.0).
The risk was significantly increased in patients with a history of peptic ulcer
and/or upper gastrointestinal bleeding, and in those taking antiplatelet drugs.
CONCLUSIONS: NSAID-induced upper gastrointestinal bleeding is a common cause of
hospital admission. Apart from the patient's history of peptic ulcer, its risk
depends on the particular drug and its dose, and on concomitant treatments. Our
results do not confirm that grea
2.) Nimesulide-induced severe hemolytic anemia and acute
liver failure leading to liver transplantation.
Scand J Gastroenterol. 2002 Nov;37(11):1341-3.
Rodrigo L, de Francisco R, Perez-Pariente JM, Cadahia V, Tojo R, Rodriguez M,
Lucena MI, Andrade RJ.
Gastroenterology Service, Hospital Central de Asturias, Oviedo, Spain.
We present the case of a 63-year-old woman who had undergone 7 months of
treatment with Nimesulide (100 mg/b.i.d.) for symptomatic osteoarthritis. The
patient was admitted to our unit with a clinical picture of progressive jaundice
over 3 weeks. Clinical and analytical studies revealed acute liver failure, this
being confirmed by liver biopsy, which showed submassive necrosis. Serological
tests for different viral agents causing hepatitis were all negative. In
addition, she presented a picture of severe haemolytic anaemia resistant to
several treatments and needed multiple transfusions. Twenty-three days after
admission, the patient presented hepatic encephalopathy and received an
orthotopic liver transplant on day 25. The evolution after transplantation was
good and the patient continues in good health with no evidence of haemolysis
almost 2 years later. Liver toxicity due to Nimesulide is well known, but to our
knowledge the occurrence of haemolytic anaemia has not been related to this drug
previously. For these reasons, Nimesulide has been restricted or removed from
the market in several countries in recent months.
3.) REMINYL® (Galantamine) Reduces Rate of Alzheimer's
Disease Progression By More Than 50 Percent Over Four Years of Therapy.
Source: http://www.jnj.com/
Helsinki, Finland (September 2, 2003) – Treatment with REMINYL® (galantamine)
can reduce the cognitive deficits of Alzheimer's disease (AD) by more than 50
percent when used continuously for four years, according to research presented
at the 7th Annual Congress of the EFNS (European Federation of Neurological
Societies).
In the largest long-term study of its kind, 240 AD patients were treated with 24
mg of galantamine daily for 48 months. When the cognitive performance (ability
to think, reason and learn) of patients on treatment was compared to that
expected from the course of the disease in untreated individuals, it was found
that galantamine treatment delayed the natural course of decline by more than
half. Scores on the cognitive portion of the Alzheimer’s Disease Assessment
Scale (ADAS-Cog) deteriorated by an average of only 12.8 points among
galantamine patients, compared to an expected drop of 26-32 points in untreated
cases.1
Commenting on the findings, study investigator Susanne Schwalen, M.D.,
neurologist and European Medical Affairs Director of Jansen-Cilag, said, "Patients
treated continuously with REMINYL® gained 12-18 months' preservation of their
cognitive function, significantly postponing their loss of independence, while
reducing the burden on caregivers. Additionally, more than 12 percent of REMINYL®
patients did not deteriorate at all during the course of the study."
Importantly, the study also confirmed the safety profile of long-term
galantamine treatment. The most frequently reported side effects were agitation,
falls and urinary tract infection – characteristic of any elderly population.
The incidence of side effects such as nausea and vomiting, typically seen with
other Alzheimer's treatments, was very low.
Experts believe the long-term efficacy of galantamine may be a result of its
unique dual mechanism of action. Like other Alzheimer's disease treatments,
galantamine enhances levels of the neurotransmitter acetylcholine (a chemical "messenger"
responsible for sending signals between nerve cells in the brain), which is
typically deficient in Alzheimer's disease. However, unlike the others,
galantamine also has a modulating effect on the brain's nicotinic receptors,
increasing their effectiveness. Nicotinic receptors are thought to play a key
role in attention, memory and learning.
REMINYL® (galantamine) was developed by Johnson & Johnson Pharmaceutical
Research & Development, L.L.C., under a co-development and licensing agreement
with UK-based Shire Pharmaceuticals Group plc. In Europe, the Middle-East and
Africa, REMINYL® is marketed by Janssen-Cilag with the exception of the United
Kingdom and Ireland, where it is registered and marketed by Shire under a co-promotion
agreement with Janssen-Cilag. The product is approved for the treatment of mild
to moderate Alzheimer's disease in more than 30 countries, and also is being
studied in individuals with vascular dementia, mixed vascular dementia and mild
cognitive impairment.
The Janssen-Cilag companies, part of Johnson & Johnson, one of the most
diversified health care corporations, have a long track record in developing and
marketing treatments for central nervous system disorders, pain management,
fungal infections and gastrointestinal conditions. Leading products include
EPREX® (haematology), RISPERDAL® (psychiatry), SPORAMOX® (dermatological/fungal
infections), DUROGESIC® (management of chronic, moderate to severe pain),
TOPAMAX® (neurology/epilepsy), PARIET® (gastroenterology) and REMINYL® (Alzheimer’s
disease). More information can be found at http://www.jnj.com/exit_warning.jsp;jsessionid=4TJB5AGCGHETSCQPCB3SZOYKB2IIWNSC?url=http%3A%2F%2Fwww.dementia.com
or at http://www.jnj.com/exit_warning.jsp;jsessionid=4TJB5AGCGHETSCQPCB3SZOYKB2IIWNSC?url=http%3A%2F%2Fwww.janssen-cilag.com.
Shire Pharmaceuticals Group, plc, is a global specialty pharmaceutical company
with a strategic focus on meeting the needs of the specialist physician and
currently has a range of projects and products in the areas of central nervous
system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in
the world's key pharmaceutical markets (U.S., Canada, UK, France, Italy, Spain
and Germany) as well as a specialist drug delivery unit in the U.S. For further
information on Shire, please visit the Company's Web site http://www.jnj.com/exit_warning.jsp;jsessionid=4TJB5AGCGHETSCQPCB3SZOYKB2IIWNSC?url=http%3A%2F%2Fwww.shire.com.
1 Schwalen S, Hammond G.4-Year treatment with galantamine: long-term cognition
effects in Alzheimer's disease. Abstract presented at the EFNS 2003.
4.) Drugs Approved by the
FDA/ Drug Name: Reminyl (galantamine hydrobromide)
Drugs Approved by the FDA/
Drug Name: Reminyl (galantamine hydrobromide)
Source: http://www.centerwatch.com/
The following information is obtained from various newswires, published medical
journal articles, and medical conference presentations.
Company: Janssen Pharmaceutica
Approval Status: Approved February 2001
Treatment for: Mild to moderate dementia of the Alzheimer's type
General Information
Reminyl is an Alzheimer's treatment derived from the bulbs of the daffodil,
Narcissus pseudonarcissus. It is believed that neurons producing the
neurotransmitter acetylcholine degenerate in the brains of patients with
Alzheimer's disease. This loss of acetylcholine has been correlated with
decreased cognitive function (thinking, remembering and reasoning). Reminyl
works to increase the concentration of acetylcholine by blocking the action of
acetylcholinesterase, an enzyme that catalyzes the hydrolysis (break down) of
acetylcholine.
An estimated four million Americans have Alzheimer's disease -- a progressive
loss of cognitive function so severe that it interferes with an individual's
ability to function. The number is expected to grow to 14 million by the middle
of the next century. The disorder is the third-most expensive illness in the
United States, behind only heart disease and cancer.
Reminyl was developed by the Janssen Research Foundation under a co-development
and licensing agreement with the UK-based Shire Pharmaceuticals. The drug will
be marketed by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical in the
United States.
Clinical Results
In trials ranging from 12 to 26 weeks, the effectiveness of Reminyl was measured
using two primary tools. Subjects' abilities in terms of memory, orientation,
reasoning and language were assessed using the cognitive portion of the
Alzheimer's Disease Assessment Scale (ADAS-cog). Across all trials, results
demonstrated that more subjects taking Reminyl showed significant improvement in
their cognitive performance than subjects taking placebo.
The second primary measure of effectiveness was the Clinician's Interview-Based
Impression of Change plus Caregiver Information (CIBIC-plus), which provides an
overall assessment of patient functioning - including behavior, organized
thinking and activities of daily living (such as dressing, eating and managing
family finances). The CIBIC-plus results from all trials also showed that the
overall scores for subjects taking Reminyl were statistically superior to
placebo.
Side Effects
Adverse events reported with Reminyl use include (but are not limited to) the
following:
Nausea
Vomiting
Diarrhea
Anorexia
Weight loss
The most frequent adverse events associated with the use of Reminyl can be
minimized by following the recommended dosage and administration.
Because this list is not all-inclusive, please consult a physician to discuss
any side effects and the individual appropriateness of the drug.
Mechanism of Action
Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of
acetylcholinesterase. While the precise mechanism of galantamine's action is
unknown, it may exert its therapeutic effect by enhancing cholinergic function.
This is accomplished by increasing the concentration of acetylcholine through
reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is
correct, galantamine's effect may lessen as the disease process advances and
fewer cholinergic neurons remain functionally intact. (from Reminyl Prescribing
Information).
Additional Information
Reminyl is given in a tablet formulation, with 4 mg, 8 mg or 12 mg dosages. The
drug should be taken twice a day, preferably with morning and evening meals.
For more information on Reminyl, please visit Janssen Pharmaceutica.
Additional information on Alzheimer's disease can be obtained by visiting the
Alzheimer's Association.
5.) Xeloda® Improves Recurrence-Free Survival over 5-Fluorouracil/Leucovorin in
Metastatic Colorectal Cancer.
Source: http://cancerconsultants.com/
According to results recently presented at the 40th annual meeting of the
American Society of Clinical Oncology (ASCO), the oral chemotherapy agent Xeloda®
(capecitabine) increases recurrence-free survival and reduces side effects
compared to intravenous 5-fluorouracil and leucovorin in the treatment of
metastatic colorectal cancer.
Colorectal cancer remains the second leading cause of cancer deaths in the
United States. Metastatic colorectal cancer refers to cancer that has spread
from its site of origin to several and/or distant sites in the body.
Chemotherapy with or without biologic therapy remains the mainstay of treatment
for patients with metastatic colorectal cancer. Combinations of chemotherapy
agents are typically used in the treatment of colorectal cancer, with the agents
5-fluororacil (5-FU) and leucovorin (LV) being used in virtually every
combination or used as treatment alone.
5-FU/LV is administered into a vein (intravenous), creating potential risks for
pain, infection, increased use of medical resources, increased time for
administration and increased medical costs, compared to oral administration of
drugs. Xeloda® is an oral chemotherapy agent that gets converted to the “active”
form of 5-FU in the body. Researchers have been evaluating Xeloda® in the
treatment of various cancers, with results indicating comparable efficacy to
5-FU/LV in colorectal cancer with minimal side effects and the added convenience
of oral administration.
A multi-institutional clinical trial was recently conducted to compare Xeloda®
to 5-FU/LV in the treatment of metastatic colorectal cancer. This trial included
164 medical centers and nearly 2,000 patients. Patients were treated with either
Xeloda® as a single agent or 5-FU/LV and were directly compared. At 3 years,
cancer-free survival was 64.2% in patients treated with Xeloda®, and 60.6% in
patients treated with 5-FU/LV, and relapse-free survival was 65.5% for those
treated with Xeloda®, compared with 61.9% for those treated with 5-FU/LV.
Overall survival was 81.3% in patients treated with Xeloda®, compared with 77.6%
in patients treated with 5-FU/LV. Patients treated with 5-FU/LV had higher rates
of diarrhea, nausea and vomiting, hair loss, low white blood cell levels,
infection and mouth sores. Patients treated with Xeloda® had higher rates of
pain, burning and peeling of hands and feet.
The researchers concluded that Xeloda® significantly improves recurrence-free
survival and reduces side effects compared to 5FU/LV in the treatment of
metastatic colorectal cancer. In addition, Xeloda® has the added convenience of
oral administration compared to the intravenous delivery of 5FU/LV. Patients
with colorectal cancer who are to receive 5FU/LV as part of their treatment
regimen may wish to speak with their physician about the risks and benefits of
Xeloda® as part of their treatment.
Reference: Cassidy J, Scheithauer W, McKendrick J, Kroning H, et al.
Capecitabine (X) vs bolus 5-FU/leucovorin (LV) as adjuvant therapy for colon
cancer (the X-ACT study): Efficacy results of a phase III trial. Proceedings
from the 40th annual meeting of the American Society of Clinical Oncology, held
in New Orleans LA, June 5-8, 2004; Abstract #3509.
6.) VALDECOXIB Y PARECOXIB SODICO: SEVERAS REACCIONES CUTANEAS Y
DE HIPERSENSIBILIDAD.
Source:
http://www.minsa.gob.pe/infodigemid/alertas/alertas/ALERTA1203.pdf.
INISTERIO DE SALUD Dirección General de Medicamentos, Insumos y Drogas Año de
los Derechos de la Persona con Discapacidad y del Centenario del Nacimiento de
Jorge Basadre Grohmann
ALERTA DIGEMID N° 12 - 2003
La Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) del Ministerio
de Salud, comunica a los profesionales de la salud, instituciones,
establecimientos farmacéuticos y público en general, la modificación del inserto
de los medicamentos cuyo principio activo es el VALDECOXIB antiinflamatorio no
esteroideo inhibidor selectivo de la enzima ciclooxigenasa (COX-2) y el
PARECOXIB SODICO, pro-droga del Valdecoxib. Esta decisión se basa en la Alerta
N° 106 de la Organización Mundial de la Salud, que hace referencia a información
de la Agencia Europea de Evaluación de Medicamentos (EMEA) sobre el riesgo de
serias reacciones adversas que incluyen Síndrome de Stevens-Johnson, necrolisis
epidérmica tóxica, eritema multiforme y dermatitis exfoliativa así como
anafilaxia y angioedema por el uso de estos principios activos. En nuestro país
el principio activo VALDECOXIB se encuentra registrado con el nombre de BEXTRA
40 mg tabletas elaborado por Searle de México S.A. de C.V. y el principio activo
PARECOXIB con el nombre de DYNASTAT 40 mg, polvo estéril para inyección
elaborado por Searle Ltd. de USA y DYNASTAT 20 mg. polvo estéril para inyección
elaborado por Searle & Co. De Puerto Rico. Estos medicamentos son importados por
Droguería Pharmacia Upjohn Interamerican Corporation Sucursal del Perú. El
inserto de los productos que contienen VALDECOXIB Y PARECOXIB deberán incluir,
además de la información aprobada en el Registro Sanitario lo siguiente: -
Valdecoxib y Parecoxib están contraindicados en pacientes con historia de
hipersensibilidad a las sulfonamidas. - Se han reportado reacciones de
hipersensibilidad que incluyen anafilaxia, angioedema y reacciones cutáneas
severas como eritema multiforme, dermatitis exfoliativa, Síndrome de Stevens-Johnson
y necrólisis epidérmica tóxica asociadas al uso de VALDECOXIB, que no pueden
excluirse para PARECOXIB (pro-droga de valdecoxib). En relación a lo expuesto, a
fin de evitar problemas que se puedan derivar del uso de este medicamento, la
DIGEMID recomienda se tenga en consideración esta información y se comunique
todo efecto adverso relacionado con el uso de este principio activo. 1 Abr. 03 BMJ
2001;322:452 ( 24 February ) / News
7.) DYNASTAT® / Parecoxib.
Souurce:
Http://www.medsafe.govt.nz/
What is in this leaflet
This leaflet answers some common questions about DYNASTAT powder for injection.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you
using DYNASTAT against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or
pharmacist.
Keep this leaflet.
You may need to read it again.
What DYNASTAT is used for
DYNASTAT is used for the prevention and treatment of pain. It can be used to
relieve pain and reduce inflammation (swelling and soreness) which may occur
after surgery.
Although DYNASTAT can relieve the symptoms of pain and inflammation, it will not
cure your condition.
DYNASTAT belongs to a family of medicines called Coxibs. These medicines work by
relieving pain and inflammation.
Your doctor may have prescribed DYNASTAT for another reason.
Ask your doctor if you have any questions about why DYNASTAT has been prescribed
for you.
DYNASTAT is not addictive.
This medicine is available only with a doctor's prescription.
Before you are given DYNASTAT
When you must not use it
Do not use DYNASTAT if:
you have an allergy to:
parecoxib sodium or valdecoxib
any of the ingredients listed at the end of this leaflet
sulfonamides, a group of medicines which include, for example, certain
antibiotics (if you are not sure whether you are taking one of these medicines
ask your pharmacist).
Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or
breathing
hives, itching or skin rash
swelling, blistering or peeling of the skin
These symptoms may be severe if you are allergic to sulfonamides or to any of
the ingredients listed at the end of this leaflet and you are given DYNASTAT.
Ask your doctor or pharmacist if any of this applies to you.
you have had an attack of asthma, hives, itching, skin rash or a runny nose
after taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines
used to treat pain and inflammation).
Many medicines used to treat headache, period pain and other aches and pains
contain aspirin or an NSAID. If you are not sure if you are taking any of these
medicines, ask your doctor or pharmacist.
If you are allergic to aspirin or NSAIDs and use DYNASTAT, these symptoms may be
severe.
If you are not sure whether you should be given DYNASTAT, talk to your doctor.
Before you are given it
Tell your doctor if:
you have any allergies to:
any other medicines including aspirin or other NSAID medicines
any other substances, such as foods, preservatives or dyes
you are pregnant or intend to become pregnant.
DYNASTAT may affect your developing baby if taken during pregnancy.
Use of DYNASTAT during pregnancy is not recommended. Discuss this with your
doctor.
you are breastfeeding or intend to breastfeed.
It is not known whether DYNASTAT passes into breast milk or whether your baby
might be affected. Therefore, breastfeeding should be discontinued during
treatment with DYNASTAT.
Discuss this with your doctor.
you have or have had any medical conditions, especially the following:
kidney or liver disease
heart problems or heart surgery
high blood pressure, heart failure or fluid retention
dehydration
asthma or other allergic conditions
peptic ulcer (ie stomach or duodenal ulcer), a recent history of one, or have
had peptic ulcers before
you currently have an infection.
If you are given DYNASTAT while you have an infection, it may hide some of the
signs of an infection.
If you have not told your doctor about any of the above, tell them before you
are given DYNASTAT.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you
buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with DYNASTAT. These include:
aspirin, salicylates or other NSAID medicines
warfarin, a medicine used to stop blood clots
lithium, a medicine used to treat some types of depression
diuretics, also called fluid or water tablets
medicines used to treat high blood pressure
medicines used to treat diabetes
methotrexate, a medicine used to treat arthritis and some cancers
fluconazole and ketoconazole, both are anti-fungal agents
anaesthetics
These medicines may be affected by DYNASTAT, or may affect how well it works.
You may need to take different amounts of your medicine, or you may need to take
different medicines. Your doctor will advise you.
Your doctor and pharmacist may have more information on medicines to be careful
with or avoid while taking DYNASTAT.
How to use DYNASTAT
How much to use
DYNASTAT will be given to you by your doctor. It is diluted and given by
injection into a vein or IV line or into a muscle.
Follow all directions given to you by your doctor and pharmacist carefully. They
may differ from the information in this leaflet.
The usual recommended dose is a single 40 mg injection.
Your doctor may adjust the dosage you are given depending on your condition.
Ask your doctor if you want more information about the dose of DYNASTAT and how
it is given.
If you are given too much (overdose)
Immediately advise your doctor if you think you have been given too much
DYNASTAT. Do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention.
The symptoms of being given too much DYNASTAT may include the effects listed
under the heading, "Side effects" in this leaflet.
While you are using DYNASTAT
Things you must do
If you become pregnant while receiving DYNASTAT, tell your doctor immediately.
If you are about to start taking any new medicine, tell your doctor and
pharmacist that you are using DYNASTAT.
Tell all of the doctors, dentists, and pharmacists who are treating you that you
are using DYNASTAT.
Things you must not do
Do not take any other medication unless your doctor is aware of it.
Things to be careful of
Be careful driving or operating machinery until you know how DYNASTAT affects
you.
Side Effects
Check with your doctor as soon as possible if you have any problems when given
DYNASTAT, even if you do not think the problems are connected with the medicine
or are not listed in this leaflet.
Like other medicines, DYNASTAT can cause some side effects. If they occur, most
are likely to be minor and temporary. However, some may be serious and need
medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
changes in blood pressure
dizziness or light-headedness due to low blood pressure
back pain
a reduced sense of touch
stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion,
cramps
constipation, diarrhoea, pain in the stomach, wind
sleeplessness
irritability
sore throat
Tell your doctor immediately if you notice any of the following:
slow heart beat
severe or persistent headache
bleeding or bruising more easily than normal, reddish or purplish blotches under
the skin
signs of anaemia, such as tiredness, being short of breath, and looking pale
unusual weight gain, swelling of ankles or legs
a change in the amount or frequency of urine passed
infection of any wounds
itching, skin rash or swelling, blistering or peeling of the skin.
swelling of the face, lips, mouth, tongue or throat which may cause difficulty
in swallowing or breathing.
These are serious side effects. You may need urgent medical attention.
Other side effects not listed above may also occur in some patients. Tell your
doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience
any of them.
After using DYNASTAT
Storage
DYNASTAT will normally be stored in a hospital or doctor's surgery. It should be
stored below 25°C and should be protected from light (kept in the original
packaging before use). DYNASTAT must not be kept in a refrigerator or freezer.
Product Description
What it looks like
DYNASTAT comes in single-use glass vials, and requires dilution with normal
saline before use. It is a white to off-white powder.
DYNASTAT may be supplied along with normal saline in glass ampoules for dilution.
When diluted, DYNASTAT is a clear and colourless solution.
Ingredients
The active ingredient in DYNASTAT is parecoxib (as parecoxib sodium).
DYNASTAT contains 40 mg parecoxib per vial.
DYNASTAT also contains sodium phosphate - dibasic, phosphoric acid and sodium
hydroxide.
Identification
DYNASTAT can be identified by an Australian Register number which is found on
the carton:
DYNASTAT 40 mg - AUST R 82525*
DYNASTAT 40 mg with saline diluent - AUST R 82509
* Not available in New Zealand
Supplier
DYNASTAT is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229
DYNASTAT is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland
Toll Free Number: 0800 736 363
This leaflet was last revised in July 2004.
® Registered trademark
© Copyright Pfizer Australia Pty Ltd, 2003
8.) Parecoxib: new preparation. A NSAID for postoperative pain:
no proven advantage.
Prescrire Int. 2004 Jun;13(71):83-5.
[No authors listed]
(1) Parecoxib is the second nonsteroidal antiinflammatory drug, after ketoprofen,
to be marketed in France for the treatment of postoperative pain. (2) Another
injectable NSAID, ketorolac, was marketed briefly in the 1990s. It was shown to
be no more effective than ketoprofen, but was withdrawn from the French market
because it provoked bleeding. (3) The clinical evaluation dossier on parecoxib
contains no data from comparative trials with ketoprofen. The three trials
versus ketorolac failed to show that parecoxib was more effective. (4) The two
trials comparing parecoxib with morphine are biased by the use of a too low dose
of morphine (4 mg). Four trials show that adding parecoxib reduces morphine
requirements in patients injecting the opiate on demand. There is no evidence
that this reduction translates into a lower risk of adverse reactions to opiates.
(5) Parecoxib is marketed as "Cox-2-specific inhibitor", but follow-up is too
short to show whether this property avoids the severe adverse effects seen with
other NSAIDs, such as renal failure, gastrointestinal haemorrhage, and delayed
wound healing. Parecoxib, like its principal metabolite valdecoxib, can cause
severe hypersensitivity reactions. (6) Parecoxib is 10 times more expensive than
injectable ketoprofen in France. (7) In practice, ketoprofen is still the best
choice for parenteral NSAID-based pain relief in the postoperative setting.
9.) Bextra
/Bextra attracts the spotlight for blatant commercial use of academic journals.
Source: http://www.drugintel.com/
Like the other COX-2 Inhibitors Vioxx and Celebrex, Bextra (valdecoxib) is prone
to major side effects. Update: January 2, 2003
Bextra (valdecoxib)
Drug names
Rheumatoid arthritis, chronic analgesic
Approved medical usage
Anaphylaxis, Angioedema
and serious skin reactions including Erythema Multiforme, Exfoliative
Dermatitis,
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
Adverse effects
Pharmacia (Pfizer)
Company
Allergic reaction in a variety of body parts that may be fatal; swelling of
tissue just below skin or peeling/blistering of skin; minor or major eruptions
of the skin; severe inflammation of the entire skin, different from Skin Rash
Patient presentation
Public Citizen focus on off-label marketing using refereed, academic journal as
vehicle.
Litigation status
Contact [email protected]
Further info
Much of the concern over the COX-2 inhibitor valdecoxib arises not from clinical
trials leading to its recent approval by FDA. Rather, spontaneous adverse event
reports have come to the attention of the European counterpart of FDA, the
European Agency for the Evaluation of Medicines (EMEA) concerning a different
drug, parecoxib (Dynastat, Rayzon, Xapit). Valdecoxib is the active metabolite
of parecoxib, and so is considered highly likely to cause the same effects. EMEA
declares a "positive opinion" of valdecoxib, but this drug is not yet approved
for marketing by EMEA.
Parecoxib was scrutinized since its approval March 22, 2002, but adverse events
reported for valdecoxib motivated major revisions October 22, 2002: EMEA issued
strong warnings to the public and revised the label of parecoxib. Interestingly,
parecoxib was approved by EMEA for a much more limited use than FDA approved for
valdecoxib, namely acute pain resulting from surgery.
Much of the anaphylactic reaction resembles that which occurs in some patients
to Penicillin and related Antibiotics; Painkillers / Analgesics; and Arava..
Minor eruption of the skin is localized and transient. Major eruption of the
skin involving mucous secretions can be life-threatening.
Pharmacia is sued over promotion of off-label use of pain-killer Bextra
A consumer group has sued Pharmacia (Pfizer) for illegal Off-Label promotion of
the COX-2 inhibitor Bextra (valdecoxib). Pharmacia hired the clinical testing
group Scirex to study the use of Bextra in acute pain associated with impacted
molars; the results were published in the Journal of the American Dental
Association for which continuing medical education (CME) credit was available.
Public Citizen criticized the use of refereed, academic journals for commercial
promotion of off-label use. Di91
Daniels SE et al., The analgesic efficacy of valdecoxib vs. oxycodone/acetaminophen
after oral surgery. J Am Dent Assoc. 2002 May;133(5):611-21; quiz 625.
Opinion: The manipulation of academic, peer-reviewed medical research journals
is one of the greatest flaws in American medicine. Physicians and medical
research scientists and their organizations (medical schools, societies such as
the American Medical Association (AMA) have allowed themselves to become
dependent on this source of financial support and as a result objectivity is
compromised. In legal terms, the fact of this relationship makes the Daubert
criteria for admission of evidence strongly favorable to the interests of the
pharmaceutical industry. The Daniels et al. publication is unusual in that the
conflict of interest is very obvious, whereas most of the influences of this
type are (intentionally or inadvertently) subtle.
See also COX-2 Experts; see also COX-2 Inhibitors deflate further; see also
Vioxx.
Information on Medication Bextra: Symptoms - Rash, Pimple, Pimples, Swelling,
Anaphylaxis, Angioedema, Erythema Multiforme, Exfoliative
10.) Prolonged thrombocytopenia associated with
isotretinoin.
Ann Pharmacother. 2003 Nov;37(11):1622-4.
Moeller KE, Touma SC.
Department of Pharmacy Practice, The University of Kansas Medical Center, Kansas City, KS 66160-7231, USA. [email protected]
OBJECTIVE: To report a case of severe prolonged thrombocytopenia possibly
associated with isotretinoin. CASE SUMMARY: A 27-year-old white woman developed
severe thrombocytopenia and elevated transaminases after 3(1/2) months of
treatment with isotretinoin. Prior to the onset of thrombocytopenia, the patient
had also received a 10-day course of cephalexin. Rectal bleeding was reported by
the patient, who was otherwise asymptomatic. Liver enzyme values returned to
normal approximately 1 week after discontinuation of isotretinoin; however,
platelet counts required approximately 2 months to normalize. Based on the
Naranjo probability scale, possible causality exists between isotretinoin and
thrombocytopenia. DISCUSSION: The exact mechanism by which isotretinoin caused
thrombocytopenia in this patient is not clearly understood. To our knowledge,
only 3 previous cases of isotretinoin-associated thrombocytopenia have been
reported. The long recovery process that occurred in our patient is possibly a
direct result of the long elimination half-life of both the parent compound and
active metabolites of isotretinoin. CONCLUSIONS: Clinicians prescribing
isotretinoin should be aware of the potential life-threatening consequence of
thrombocytopenia, and a complete blood cell count with platelets should be part
of the routine monthly monitoring in all patients receiving isotretinoin therapy.
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DATA-MEDICOS/DERMAGIC-EXPRESS /JULY JOURNAL 2.004/ DR. JOSE
LAPENTA R.
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