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Article Summary: Of these 87 cases, 36 hospitalizations were reported, including 4 deaths
Bextra Label Updated With Boxed Warning Concerning Severe Skin Reactions
The Food and Drug Administration (FDA) announced today 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.
Serious Skin Reactions:
The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-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.
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. If you or anyone you know has taken BEXTRA and has experienced the above symptoms or side effects, contact our BEXTRA lawyer and receive a free case evaluation.
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