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Stevens Johnson Syndrome and BextraPrior to its withdrawal from the market, Pfizer, at the request of the FDA, updated the label on Bextra to include warnings about potentially fatal skin disease side effects: The Food and Drug Administration (FDA) announced important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) which is indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). A "boxed" warning, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery will be added to the label. The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises 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 states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions. As of November 2004, FDA had received reports of a total of 87 cases in the United States of severe 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. If you or a loved one has been diagnosed with Stevens Johnson Syndrome, it is possible that the condition was caused by an allergic reaction to a drug. Drug manufacturers have a responsibility to notify physicians and patients of any potential harmful side effects of drugs. Please contact us immediately so we can help you in finding an attorney to help you with your potential case. |
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