Experts Split on Safety of Diet Drug Meridia

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Two months after a Food and Drug Administration advisory committee recommended stronger restrictions on the use of a popular diabetes drug, the same panel voted to impose similar limitations on the use of the diet drug Meridia.

Also known as sibutramine, the drug helps to reduce weight loss by promoting brain signals that help the body to feel full. But after studies revealed that users had a higher risk of heart attack and stroke, the FDA required the drug’s maker, Abbott, to add warnings to the label. The alert, issued earlier this year, indicated that patients with a history of heart attack, stroke, high blood pressure, arrhythmias or blood vessel problems should not use the drug.

After reviewing the results of a new trial, known as SCOUT, which compared heart risks associated with weight loss from Meridia to the risks from a placebo, none of the panel members voted to keep the drug on the market with its current labeling. The trial of overweight or obese subjects who had a history of heart problems found that Meridia users had a 11% increased risk of additional heart events compared to those taking placebo. Another study of the drug, published in the New England Journal of Medicine, found a 16% heightened risk. Half of the 16 member committee voted to removed the drug from the market, while six opted for an additional layer of regulation that would require only specially certified physicians who had been educated about the dangers of the drug to prescribe the medication. The remaining two experts voted for a new black box warning that would highlight the increased heart risks and ask physicians to monitor patients for these risks more closely. (More on Who’s High? A School Suspends a Student for Bloodshot Eyes)

Some physicians believe the benefits of Meridia are worth the added risk, since overweight and obesity carry high health risks already. Others, however, maintain that the risk in this already vulnerable group is too high, and that other weight loss measures, including medications as well as diet and lifestyle changes, can be just as effective.

The final decision about Meridia rests with FDA commissioner Margaret Hamburg and her office. In most cases, the FDA follows the advice of its advisory committees. (More on Evidence Review: Anti-Drinking Drug Shows Modest Success)

But Hamburg is under particular scrutiny on the issue of drug safety, since she now has to make a decision about a series of medications like Meridia that have proven unsafe after they were greenlighted by the FDA. Earlier this summer, concerns about heart risks associated with the diabetes drug rosiglitazone, or Avandia, resulted in a vote that kept the drug on pharmacy shelves, but opened the door for Hamburg to pull it—in that meeting, experts voted 17 to 12 to keep the drug, but with stricter regulation of its use. Later this week, the committee will consider safety concerns about another diet drug, lorcaserin, which works by blocking appetite receptors in the brain. Studies have shown that the drug may lead to memory problems and heart valve damage.

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