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The Food and Drug Administration (FDA) has announced its intention to strengthen its warnings about Pfizer's BEXTRA®, which is an anti-inflammatory drug used as an alternative to Merck's Vioxx®.
The FDA said "a boxed warning, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning cautioning against the use of Bextra® in patients undergoing coronary artery bypass graft (CABG) surgery will be added to the label." The new boxed warning label states that patients taking Bextra® have reported serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis.
The labeling also 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 or allergic reactions. The new boxed warning also states that Bextra® contains sulfa, which if a patient has a history of allergic reactions to sulfa they may be at a greater risk of skin reactions.
As of November 2004 the FDA has received reports of 87 cases in the U.S. of severe skin reactions associated to Bextra®, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. Of these 87 cases, 36 hospitalizations were reported, including 4 deaths.
The FDA is also seeking input from the public and from outside experts on the appropriate uses for Bextra® and other non-steroidal anti-inflammatory drugs (NSAIDs) at a previously publicized Advisory Committee meeting, to be held in early 2005.
Cardiovascular Risks
A recent study by Pfizer of over 1,500 patients treated after coronary artery bypass graft (CABG) surgery showed an increased cardiovascular risk in patients treated with Bextra® compared to the placebo. Observed cardiovascular risks include thromboembolic events such as heart attack, stroke, deep vein thrombosis (blood clots in leg), and pulmonary embolism (blood clot in the lung). Pfizer submitted the final report of the CABG study to the FDA on November 5, 2004.
The FDA believes that these new findings should be made available to healthcare professional and patients, and the bolded warning specifically contraindicates Bextra® for treatment of pain immediately following a CABG surgery. Bextra® is not approved for use in treatment of postoperative pain of any type.
If you believe that you or a relative were injured by taking Bextra® please use the form below to contact our law firm.
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