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Kaiser To Stop Dispensing Painkiller Bextra

FDA To Review Safety Of Cox-2 Inhibitors

POSTED: 10:20 am EST January 31, 2005

Kaiser Permanente, the nation's largest nonprofit managed-care provider, has stopped prescribing Bextra until tests show whether the painkiller is safe.

Bextra, which is made by Pfizer Inc., is a nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis, rheumatoid arthritis and menstrual pain.

Word of the decision came in a company memo issued by Kaiser. The memo says the decision came amid "compelling" evidence of heightened heart risks associated with Cox-2 inhibitors such as Bextra and Vioxx, a similar drug that manufacturer Merck & Co. pulled from the market in September.

A Kaiser spokeswoman said the policy, which Kaiser is calling a moratorium, represents the first time the health system's doctors had decided to stop dispensing a drug that was approved by the Food and Drug Administration.

The FDA plans to review dozens of studies of Cox-2 inhibitors that are now under way. The agency plans to convene an advisory panel in February to review all the available information on the drugs.

Last month, the FDA announced the addition to a "boxed" warning on the drug's label, including a bolded warning about the use of Bextra in patients undergoing coronary artery bypass graft surgery. The warning also strengthens previous warnings about the risk of life-threatening skin reactions.

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