Bextra Serious Skin Reactions

One of the major reasons the FDA requested Pfizer toremove Bextra from the marketplace is that patients taking Bextra reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These reactions mostly occur in the first two weeks of treatment, but can occur any time while taking the drug.

Other drug, such as naproxen and ibuprofen, also have a risk for these rare, serious skin reactions. However, the reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents.

Some of these serious skin reactions have been fatal. Before its removal, the FDA ordered new labels for Bextra which advised doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions (such as sores on the inside of the mouth), or any other sign of allergic reactions.

The warning included the fact Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.

FDA officials received reports of 87 US cases of severe serious skin reactions in association with Bextra, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Twenty of the 87 cases involved patients with a known allergy to sulfa. Of these 87 cases, 36 hospitalizations were reported, including four deaths.

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