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Weight-Loss Drug Meridia Pulled From U.S. Market
Date:10/9/2010

By Steven Reinberg
HealthDay Reporter

FRIDAY, Oct. 8 (HealthDay News) -- The obesity drug Meridia has been withdrawn from the U.S. market because of an increased risk of heart attack and stroke, federal health officials said Friday.

Pharmaceutical giant Abbott Laboratories voluntarily agreed to pull the drug after a U.S. Food and Drug Administration review of data that showed a 16 percent increased risk for heart attack, stroke and death among people taking Meridia (sibutramine), compared with those taking a placebo.

Earlier Friday, Health Canada, the nation's health department, said Abbott would voluntarily pull the drug from the market there.

"FDA requested this withdrawal after concluding that the continued availability of this product is not justified since patients taking the drug are at an increased risk of suffering a heart attack or stroke," Dr. John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said during an afternoon news conference.

Besides finding an increased risk of heart attack and stroke, the review trial, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), found only a small difference in weight loss among those taking the drug and those receiving a placebo, agency officials said.

"Physicians are advised to stop prescribing Meridia to their patients, pharmacists are advised to stop dispensing Meridia, and patients are advised to stop taking this drug and dispose of any remaining product," Jenkins said.

Jenkins advised those taking Meridia, which is a stimulant, to discuss with their doctor other ways to lose weight.

Currently, about 100,000 people in the United States take Meridia, Dr. Gerald Dal Pan, director of FDA's Office of Surveillance and Epidemiology, noted at the news briefing.

In a news release, Abbott said the company "believes sibutramine has a positive risk/benefit profile in the approv
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