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

red 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]."

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