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Bextra was FDA approved on November 16, 2001 to treat signs and symptoms of osteoarthritis, adult rheumatoid arthritis and for the treatment of primary dysmenorrhea. Bextra is part of a class of drugs called cox-2 inhibitors, which belongs to a larger group called nonsteroidal anti-inflammatory drugs (NSAIDs). While NSAIDs include common, over-the-counter drugs like aspirin, cox-2 inhibitors were seen as a breakthrough to relieving pain and inflammation because of its ability to protect the stomach lining unlike the over-the-counter drugs. As a result, Bextra and other cox-2 drugs were believed to be safer on the stomach and less likely to cause bleeding ulcers that were associated risks to older NSAIDs.
As more studies were performed, this cox-2 benefit began to unravel, with more experts questioning if a real advantage exists. Bextra warnings indicated the drug''s ability to protect the stomach might not be as strong as initially believed and that cox-2 inhibitors did not actually eliminate gastrointestinal side effects, rather just reduced them on some level. Another popular cox-2 Pfizer drug called Celebrex was included in a September 2000 study of 8,000 patients, finding Celebrex had fewer ulcer complications when compared to those taking over-the-counter drugs over a six-month time. A later analysis by the FDA looked at 12 months of data and found that the six-month advantage of the cox-2 drug had all but disappeared.
After one year on the market, Pharmacia, the manufacturer of Bextra, Pfizer and the FDA issued Bextra warnings in November 2002 by updating Bextra labels and sending out "Dear Healthcare Professional" letters. Changes were issued after postmarketing experience showed rare and spontaneous reports of hypersensitivity reactions. Since marketing of Bextra began in March 2002, cases of serious skin and hypersensitivity reactions were reported, including cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme.
The Bextra warning notified healthcare professionals to be aware of the serious skin reactions reported that sometimes required patients to be hospitalized. Since the adverse effects can be life-threatening, the Bextra warning advised Bextra patients that experience a rash should immediately discontinue the use of the drug. As the controversy over cox-2 inhibitors and the question of whether they actually do deliver safer pain relief continued, more troublesome hints drastically slowed the growth of all cox-2 inhibitors as well as delaying approval of any new cox-2 drugs.
Perhaps the most troublesome Bextra warnings are the hints that cox-2 drugs might increase risk of heart disease. Although cox-2 trials have shown evidence that the pain relievers might increase a person''s risk of heart disease, experts think researchers need to specifically study arthritis patients who already have coronary heart disease or are in a high risk group of developing it soon to know if cox-2 inhibitors are safe for patients with heart disease. Only then can the debate be more properly settled and any additional, more conclusive Bextra warnings issued.
Pfizer''s Celebrex and Bextra, part of the cox-2 class, has seen the entire growth of the group stalled as controversy instead has surrounded the drugs. With the release of the initial Bextra warning followed up by debate over the efficacy and safety of cox-2 drugs compared to over-the-counter drugs, many patients are wondering if their pricey, name brand drugs are really superior to drugstore available pills like Tylenol and Advil.
Bextra , the popular cox-2 inhibitor recalled by Pfizer, is the subject of another lawsuit.
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