LYCOS RETRIEVER
Bextra
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Bextra® is a prescription drug used to treat arthritis joint pain, inflammation, and stiffness, as well as painful menstrual cramps. The brand name for valdecoxib, Bextra® is in a relatively new class of NSAIDs (non-steroidal anti-inflammatory drugs) known as COX-2 inhibitors. Some other well-known COX-2 inhibitors include Celebrex® (celecoxib), Vioxx® (rofecoxib), and Arcoxia® (etoricoxib). These arthritis medicines are touted as providing strong pain relief without irritating the stomach lining. While Bextra® has proved to be an effective medication for the relief of arthritis symptoms, certain dangerous side effects have been reported.
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When these COX-2 inhibitors like Bextra were introduced, they relieved the pain of inflammation like arthritis without causing significant stomach damage. They soon became biggest selling pain relievers in the world, with sales in the tens of billions of dollars. Unfortunately, clinical trials began to warn patients about potential risks of increased cardiovascular trauma due to the disruption by COX-2 drugs of the way that the kidneys regulate blood pressure after filtering out impurities. These drugs started causing blood clots to form in the arteries causing heart attacks and strokes. Despite the documented accounts of these risks, doctors continued to prescribe Bextra in larger quantities.
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A report presented at a meeting for the American Heart Association concluded that Bextra patients had more than double the number of heart attacks and strokes as those who were given a placebo. The report analyzed data from 12 separate clinical studies in which patients were given Bextra.
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Do not use Bextra if you have asthma and are allergic to aspirin. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. The same reactions to aspirin and other NSAID medicines happened in aspirin-sensitive patients.
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On November 13, 2002, Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported. These included cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Although these adverse events are rare, some of these patients required hospitalization. Based on these reports, FDA has approved labeling changes for Bextra that include a warning for serious skin reactions. As these reactions can be life threatening, people who start Bextra and experience a rash should contact their doctor and discontinue the drug immediately.
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In October 2002, Pharmacia (Pfizer), the manufacturer of Bextra, included a warning about serious skin reactions in their Bextra product insert revision. Prior to that, no warning was provided in the Bextra package insert. Pharmacia sent letters on November 13, 2002 to healthcare professionals about the new warnings: Bextra causing Stevens-Johynson Syndrome, erythema multiforme, toxic epidermal necrosis, exfoliative dermititis, anaphylactoid reactions and angiodema. They ... warned that Bextra should not be given to patients who are sulfa allergic, as these reactions could be life threatening. An excerpt from the letter reads: