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 Bextra Skin Reactions
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 In a few cases, these serious skin reactions resulted in death. Before it was removed, the FDA ordered new labeling for Bextra advising 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 new boxed warning also stated that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.
The FDA had received reports of a total of 87 cases in the US 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 4 deaths.
Other Cox-2 selective inhibitors and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but the reported rate of these serious side effects appears to be greater for Bextra than for other COX-2 agents. |
| One of the reasons the FDA asked Pfizer to remove Bextra from the market was that patients taking Bextra reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These serious skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy.
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