According to a study published in the New England Journal of Medicine, overweight people with a history of heart disease who take the weight-loss drug Meridia may be at increased risk of heart attack or stroke. The Food and Drug Administration (FDA) advisory committee on endocrinologic and metabolic drugs is scheduled to discuss the possibility of increased regulation for Meridia on September 15, 2010. The meeting was prompted by the preliminary results from the SCOUT study that were released by the agency in November 2009.
During the study, sponsored by Abbott Laboratories, researchers followed 10,744 overweight and obese people who had heart disease or type 2 diabetes and a risk factor for heart disease (such as high blood pressure) for about 3.5 years. During that period, 4.1 percent of those taking Meridia had a nonfatal heart attack, while 2.6 percent had a nonfatal stroke, reinforcing that Meridia should not be prescribed to people with existing heart problems. Meridia has been known to slightly raise blood pressure and heart rate, and health care providers have been aware of the associated cardiovascular risk has been known for years.
The active ingredient in Meridia, sibutramine, suppresses appetite by affecting levels of the brain chemicals serotonin and norepinephrine. The drug is designed to be used by overweight and obese people, not by people who are trying to slim down for swimsuit season. Since its FDA approval in 1997, Meridia's label has carried the warning on its label that says the drug should not be used in people with a history of heart disease, heart failure, heart-rhythm problems, or stroke. After reviewing the SCOUT study data, the FDA has asked that Abbott strengthen the warning.
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