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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FDA OKs Bextra for treating arthritis - Brand Watch - Pharmacia, Pfizer drug - Brief Article
From Drug Store News, 12/17/01 by Saskia De Caires

Pharmacia and Pfizer last month reported that the FDA has approved Bextra (valdecoxib) tablets), a cox-2 specific inhibitor, for treating the signs and symptoms of osteoarthritis, adult rheumatoid arthritis and menstrual cramping pain.

Bextra is indicated for arthritis in a once-a-day 10 mg dose, and offers 24-hour pain relief. According to the companies, global clinical trials demonstrated that B extra offers an unproved gastrointestinal safety and tolerability profile compared with conventional non-steroidal antiinflamatory drugs, specifically naproxen, ibuprofen and diclofenac.

For menstrual pain, the recommended dose of B extra is 20 mg, administered twice daily. Approximately 80 percent of women in the clinical trials required only one dose of medication within the first 24 hours.

COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2001 Gale Group

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