Abbott Laboratories will finally withdraw its diet pill Meridia in the U.S. and Canada. This comes almost a year after studies showed the drug increases the risk of heart attack and stroke in patients with a history of heart disease. The Food and Drug Administration says it requested the withdrawal because the drug’s risks were not justified compared with “the very modest weight loss that people achieve on this drug.” Dr. John Jenkins, the FDA’s director for new drugs, said in a statement:
Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication.
On this same 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 heart disease had an 11% chance of heart attacks or stroke while taking the drug compared with a 10% 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 that were filled 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. Abbott, which is based in Chicago, says it still believes its drug has a positive risk-benefit profile, but the company agreed to comply with the FDA’s request. A panel of FDA advisors had 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.
Source: Associated Press
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