Bextra Recalled Due to Increased Risks of Heart Attacks, Strokes, and Stevens-Johnson Syndrome

The FDA has asked Pfizer to withdraw Bextra (valdexocib) from the market because, like other COX-2 inhibitor drugs, Bextra has been associated with increased cardiovascular risks such as heart attack and stroke. In addition, Bextra is linked to the potentially life-threatening skin reaction called Stevens-Johnson Syndrome. Pfizer agreed to suspend sales and marketing of Bextra in the US and Europe.

The safety of Bextra and other drugs in the COX-2 inhibitor class came to the FDA's attention in the Fall of 2004, when Merck voluntarily withdrew the COX-2 painkiller Vioxx from the market after numerous reports of heart problems and other adverse drug reactions were submitted from doctors and patients.

Bextra's manufacturer, Pfizer, in an April 2005 press release, said it disagreed with the FDA's position that the overall safety profile of Bextra is unfavorable, meaning the risk of serious side effects outweighs the benefits of Bextra. Further, despite agreeing to suspend sales of Bextra in the US and in the European Union in early April 2005, Pfizer said it may attempt to bring Bextra back to the market some time in the future.

• FDA Public Health Advisory April 7, 2005
• FDA COX-2 Drug Information Page
• FDA Questions and Answers for COX-2 Drugs

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