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Did the Food and Drug Administration (FDA) know about these allergic reactions?

Yes. The FDA announced on November 15, 2002, that it had received about 20 reports of serious reactions, including skin diseases [Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis, and erythema mutliforme (EM)] and hypersensitivity reactions (anaphylactic reactions and angioedema). Pharmacia had issued a “Dear Healthcare Professional” letter two days earlier. Previously, on October 22, the European Medicines Evaluation Agency (the European counterpart to the FDA) issued a public statement warning of the same side effects due to taking Bextra. Unfortunately, all this came too late for Bextra patients who have been suffering from the serious and potentially fatal drug allergic reactions like Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM).

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