WEDNESDAY, Sept. 15 (HealthDay News) -- U.S. health advisers were split Wednesday over whether the diet drug Meridia should be pulled from the market, because of evidence that it increases the risk of heart attack and stroke.
Members of an advisory panel to the U.S. Food and Drug Administration who said the drug should remain available to consumers called for new warnings and restricted distribution of the drug, the Associated Press reported.
While the FDA is not bound to follow the recommendations of its advisory committees it typically does so.
European regulators banned the drug earlier this year, the AP noted.
In documents released Monday ahead of the panel meeting, the FDA said that members of its Endocrinologic & Metabolic Drugs Advisory Committee would be asked to consider a number of options, including taking no action, adding label warnings and/or restrictions to the use of Meridia, or to withdraw Meridia from the U.S. market. The drug is made by Illinois-based Abbott Laboratories.
The meeting comes on the heels of a study released earlier this month that linked the drug to an increased risk of nonfatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems.
The trial involved almost 11,000 older, overweight or obese adults with type 2 diabetes or heart disease or both who were randomly chosen to take either Meridia or a placebo and followed for about 3.4 years.
In the group taking Meridia, 11.4 percent had a heart attack, stroke or died as the result of a heart problem, versus 10 percent in the control group, a 16 percent increase.
People taking Meridia also had a 28 percent higher risk for nonfatal heart attack and a 36 percent raised risk for nonfatal stroke, compared to those taking a placebo, the researchers found.
The study stir
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