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FDA Advisers Divided on Whether to Ban Diet Drug Meridia
Date:9/16/2010

By Amanda Gardner
HealthDay Reporter

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 stirred mixed reactions from experts.

According to the authors of the trial, which was funded by Meridia's maker, Abbott, the findings were generally in line with what has been known about the drug and shouldn't change how it is used.

"The only time you've got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who . . . should never have received the drug in the first place," said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which was published in the Sept. 2 issue of the New England Journal of Medicine.

Since January, Meridia (sibutramine) has carried a label warning that it should not be used by people with preexisting heart disease, so "the current prescription is entirely appropriate," James said.

However, not everyone agreed.

According to Dr. Greg Curfman, executive editor of the NEJM and co-author of an accompanying editorial, the FDA's January warning was based on preliminary information only. The new study results represented the first hard data, "the first outcomes trial," he said.

Based on the findings, he and others wondered if the drug was worth keeping around.

The drug did not seem to make people healthier, Curfman said. "Some people were actually made worse," he said. "All this taken together results in an unfavorable risk-benefit profile and, based on that, we don't see a rationale for keeping this on the market."

Also, he said, "the efficacy of producing weight loss with the drug is very unimpressive. In this trial, patients lost on average less than 4 kilograms [about 9 pounds] and we know that that's not going to translate into a real health benefit over time. It's not enough weight loss. The FDA has a benchmark of about 5 percent loss of baseline body weight to consider a weight-loss drug [effective]."

Another expert agreed that relying on any pill for substantial weight loss may be unrealistic.

"Good old-fashioned diet and exercise is the only substantive sustained therapy that's shown to be helpful," said Dr. J. Chad Teeters, an assistant professor of clinical medicine, cardiology division at the University of Rochester Medical Center in New York. "There's no quick-fix pill."

More information

There's more on Meridia at the U.S. National Library of Medicine.

SOURCES: Philip T. James, M.D., D.Sc., professor, London School of Hygiene and Tropical Medicine, U.K.; Chad Teeters, M.D., assistant professor, clinical medicine, cardiology division, University of Rochester Medical Center, Rochester, N.Y.; Greg Curfman, M.D., executive editor, Sept. 2, 2010, New England Journal of Medicine; Sept. 13, 2010, briefing document, Web site, U.S. Food and Drug Administration; Associated Press


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