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Bextra Bextra® (valdecoxib) is a prescription COX-2 inhibitor used to treat adult rheumatoid, osteoarthritis, and the pain associated with menstrual cramps. COX-2 inhibitors are a class of drugs which inhibit COX-2, an enzyme involved in the inflammation pathway. They selectively target the COX-2 enzyme thereby reducing gastrointestinal toxicity. COX-2 inhibitors are one of the NSAIDS (nonsteroidal anti-inflammatory drugs). Bextra is similar to Vioxx, another COX-2 inhibitor which was withdraw from the market in September because of concerns that it produces an increased risk of heart attacks, strokes and Stevens Johnson Syndrome. Recent reports show that Bextra may be more likely to cause Heart Attacks and Stroke than Vioxx. Additionally, Pfizer has recenty said they will most likely add a black box warning to Bextra about Stevens Johnson Syndrome. Bextra is marketed by Pharmacia Corporation and Pfizer Inc. in the United States. In November 2004, an associate director of science in the FDA's office of drug safety told a Senate committee that Bextra was unsafe. Some doctors have called upon the FDA to require that a "black box" warning (the strongest warning) be place in Bextra's label saying that the drug should not be used by patients with cardiovascular disease. Dr. Cawkwell, Pfizer's worldwide medical director for Bextra, recently says that Pfizer is negotiating with the FDA over what new information should be put in the drug's label. Pfizer previously agreed to a black box warning to alert physicians to a the risks of a rare but potentially fatal skin rash known as Stevens Johnson Syndrome. Patients who have severe allergies to antibiotics should not use Bextra. If you develop any of the following symptoms consult your doctor immediately. Other symptoms of Stevens Johnson Sydrome include: Skin Rash, Swelling of Face, Lips and Toungue, Difficulty Breathing, and Swelling or blistering of Skin. Also in November 2004, a study was presented at an American Heart Association meeting which suggested that the incidence of heart attacks and strokes in patients taking Bextra was double that of the placebo. The study included 5,930 patients from 12 trials and found 2.19 times the number of heart attacks or strokes among patients given Bextra as compared to patients given placebos. Pfizer says the study on Bextra is based on information that has not been published in a medical journal or been subject to independent scientific review. Pfizer says the study merely reorganizes data about Bextra presented in other settings, grouping samples that were too disparate for conclusive results. Pfizer has indicated that it will launch a long term test of Bextra in arthritis patients to examine its effect on the heart. The trial will not begin however, until the end of next year and the results will not likely be available for several more years. If you have any questions regarding your legal rights, please fill out our Free Case Evaluation Form. Choose the state where you live to locate a Bextra lawyer near you. |
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