Policy-ish

FDA Ask Questions About Meridia Weight-Loss Pill

The Food and Drug Administration is taking a look at the safety of Meridia, a weight-loss pill, in the wake of information from a clinical study that suggests there may be a risk of cardiovascular problems for some people taking the medicine.

A man tries to fasten pants around his big belly. i i
iStockphoto.com
A man tries to fasten pants around his big belly.
iStockphoto.com

The agency says it's just starting to look at data that came in earlier this month from a study called SCOUT, started in 2002. The study enrolled 10,000 overweight people with significant cardiovascular risks, such as diabetes, and compared how they did on the drug with others who took a sugar pill.

The FDA says preliminary data show reports of cardiovascular events, including heart attacks and strokes, in 11.4 percent of patients taking Meridia compared with 10 percent of those taking a placebo.

Though that difference appears small, it's higher than expected and suggests there may be a problem. In an advisory, FDA cautioned it's "making no conclusion about the preliminary findings at this time."

A spokesman for Abbott Laboratories, maker of Meridia, told Dow Jones, the drug isn't recommended for more than 90% of the kinds of patients in the SCOUT study. So the company doesn't think the data should lead to any changes for the drug, approved by FDA 12 years ago.

Still, regulators have long worried that wide use of diet drugs, even in patients for whom they weren't originally intended, could lead to trouble. That concern and safety problems with past diet aids, such as fenfluramine, hang over a crop of experimental medicines in the works to help people lose weight.

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