Warnings for Bextra Strengthened (Feb 2003)
Warnings for Bextra Strengthened (Feb 2003)
In an earlier program, we talked about serious skin and hypersensitivity reactions associated with the drug Bextra (valdecoxib). Bextra is a Cox-2 selective inhibitor used to treat osteoarthritis, rheumatoid arthritis and dysmenorrhea. Now we want to tell you about strengthened warnings about these skin reactions, and also about cardiovascular risks associated with Bextra.Despite earlier warnings, FDA is still receiving reports of rare but serious skin reactions with Bextra, including Steven-Johnson Syndrome and toxic epidermal necrolysis, both of which can be fatal. So now the manufacturer, Pfizer, has added a boxed warning about this risk.Although other Cox-2 inhibitors and traditional NSAIDS also increase the risk of these skin reactions, the rate of these side effects appears to be greater for Bextra than for other COX-2 agents.So the labeling advises practitioners to watch for these skin reactions. Although they're most likely to occur during the first 2 weeks of treatment, they can occur any time during therapy. The labeling says to discontinue Bextra at the first appearance of a skin rash, mucosal lesions, or any other sign of allergic reactions. Bextra is contraindicated in patients who are allergic to sulfonamides.The new information on cardiovascular risks comes from a study that included over 1500 patients treated with Bextra for pain after coronary artery bypass surgery. The study showed that they were more likely to have cardiovascular adverse events such as MI, stroke, deep vein thrombosis and pulmonary embolism than placebo-treated patients. Bextra is contraindicated for treating pain immediately following CABG.Additional Information:FDA MedWatch Safety Alerts -- Bextra (valdecoxib). http://www.fda.gov/medwatch/SA...
Channel: News & Politics
Uploaded: December 31, 1969 at 6:59 pm
Author: LawsuitGuru
Length: 02:04
Views: 486
Tags: Bextra Cox-2 Inhibitor Osteoarthritis Rheumatoid Arthritis Dysmenorrhea FDA SJS TENS Drug Reaction Patient Safety
Video Comments
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LoveNow365 (December 31, 1969 at 6:59 pm)
I am so sorry Bextra was withdrawn from the market. It was the only thing that helped my pain. Since I used it only on an incidental basis, the side effects were not an issue. Daily I hope another similar medicine is formulated. I wait impatiently.
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