Abbott withdraws diet pill in US, Canada

October 8, 2010 By MATTHEW PERRONE , AP Health Writer

(AP) -- Abbott Laboratories said Friday it will withdraw its diet pill Meridia in the U.S. and Canada, almost a year after studies showed the drug increases the risk of heart attack and stroke in patients with a history of heart disease.

Food and Drug Administration scientists said they requested the withdrawal because the drug's risks were not justified compared with "the very modest weight loss that people achieve on this drug."

"Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication," Dr. John Jenkins, the FDA's director for , said in a statement.

Earlier in the day, Health Canada, the nation's health department, announced that Abbott would voluntarily pull the drug from the market there. Meridia has been available in both countries for more than a decade.

European regulators pulled the product off the market in January after a study showed that patients who had had an 11 percent chance of heart attacks or stroke while taking the drug compared with a 10 percent risk for those not taking it.

Regulators in the U.S. and Canada said they based their decisions on the same data.

Meridia is not widely used in the U.S., with a steep decline in prescriptions in recent years. About 283,000 prescriptions for it were filled last year, just more than half the number in 2005. The typical patient stays on the drug for about 50 days, according to FDA figures. Eighty percent of users are middle-aged women.

North Chicago-based Abbott said it still believes its drug has a positive risk-benefit profile, but agreed to comply with the FDA's request.

Last month a panel of advisers delivered a split vote of 8-8 on whether to allow continued marketing of Meridia. The FDA is not required to follow the advice of the group, though it often does.

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