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December 10, 2004

Bextra to have new warnings, says FDA

Topics: Clinical Pharmacology

Reported in Medical News Today.

Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk -

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.

...In addition, the FDA will also seek input from the public and from outside experts on the appropriate uses for Bextra and other NSAIDs at a previously-announced Advisory Committee meeting, to be held early in 2005.

.... 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. 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. Read all...

Posted by Hyscience at December 10, 2004 6:27 PM



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