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A black box warning is the strongest warning available for prescription drugs. Following the Vioxx recall, Pfizer''s rival painkillers Bextra and Celebrex have also been under scrutiny. Both of Pfizer''s drugs belong to the same Cox-2 drug class that Vioxx belonged to and the only two remaining Cox-2 drugs currently on the market. Pfizer made an announcement in its most recent quarterly report filed with the Securities and Exchange Commission Friday that a black box warning would likely be added to Bextra labeling warning of a serious skin reaction.
Bextra has been linked to reports of Stevens Johnson syndrome, which occurs when the immune system turns on itself to rid itself of a drug. The Bextra side effect can lead to severe, painful blistering of the mucous membranes and skin and patients can sometimes experience their skin coming off in sheets. Stevens Johnson has about a 30 percent mortality rate.
In mid-October, Pfizer sent letters to doctors warning of the Bextra side effect, saying the risk is the greatest during the first two weeks the drug is taken. The October letter also warned there appeared to be an increased risk of stroke and heart attack when Bextra was given to very high-risk patients who had undergone coronary bypass surgery.
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