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FDA Panel to Mull Ban on Diet Drug Meridia
Date:9/13/2010

mes, 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, sibutramine (Meridia) 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 represent the first hard data, "the first outcomes trial," he said.

Based on the findings, he and others wonder if the drug is 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. "There's no quick-fix pill."

More information

There's more on Meridia at the '/>"/>

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