Valdecoxib chemical structure
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Bextra

Valdecoxib is a prescription drug used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory drug, or NSAID, and should not be taken by anyone allergic to these types of medications. more...

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Valdecoxib was manufactured and marketed under the brand name Bextra® by G. D. Searle & Company. It was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke.

Uses

Since its registration, Bextra was prescribed for pain associated with arthritis, menstrual discomfort, and other ailments.

Side-effects and withdrawal

On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck's Vioxx. Other reported side-effects were angina and Stevens-Johnson syndrome.

Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.

Personal injury

With the removal of the drug from the market, there is expected to be a surge in personal injury claims, many in the form of class action, to seek compensation.

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New warnings for Bextra - Updates - not to be used—in patients allergic to sulfa-containing products - Brief Article
From FDA Consumer, 1/1/03

The FDA and Pharmacia Corporation are advising health-care professionals about new warnings and information in the product labeling of Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and menstrual pain (dysmenorrhea). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects, including serious allergic reactions (anaphylactoid reactions). As -these reactions can be life-threatening, people who start Bextra and experience a rash should discontinue the drug immediately. In addition, the labeling will state that the drug is contraindicated--not to be used--in patients allergic to sulfa-containing products.

Health-care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation, Peapack, N.J. at 1-800-323-4204 or to the FDA MedWatch program at 1-800-FDA-1088. For more information about how to submit a report to MedWatch, go to www.fda.gov/medwatch/how.htm.

COPYRIGHT 2003 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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