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Advisory Panel Expresses Concern About Unanswered Safety Questions

Sept. 16, 2010 -- An FDA advisory panel rejected the latest weight loss drug to make a bid for the U.S. market.

The panel of experts voted 9 to 5 to urge the FDA not to approve lorcaserin. The drug -- know by the brand name Lorqess, is made by Arena Pharmaceuticals.

The FDA doesn't have to follow the panel's recommendation, but it usually does. The vote is the latest blow to the drug industry's effort to develop safe and effective weight loss drugs.

Only two prescription drugs are approved for weight loss in the U.S. One of them, Meridia, also known as sibutramine, split the panel on Wednesday on the question of whether it should be pulled off the U.S. market because of safety concerns.

In the case of lorcaserin, the panel ruled that the modest weight loss delivered by the drug in clinical studies did not make up for several unanswered questions about its safety. In particular, panelists said they were troubled by evidence the drug increased the risk of breast tumors in laboratory animals.

Meanwhile, most patients who took lorcaserin lost relatively small amounts of weight. About half of all patients who stayed in company studies for one year lost at least 5% of their body weight. At the same time, about a quarter of patients who took a placebo achieved the same result.

In all, patients taking the drug lost only between 3% and 3.7% of their body weight beyond what they would have with a placebo, the study showed. That fell short of the FDA's criteria for an effective weight loss drug.

Diabetes and Heart Disease Patients

The company argued that even small amounts of weight loss can have positive health effects for overweight and obese adults. But experts said they were troubled that Arena's study excluded patients with diabetes and cardiovascular disease, groups that make up a large proportion of the patients who would receive the drug.

"Face it ,the people who need this have diabetes, have high blood pressure" and high cholesterol, said Lamont G. Weide, MD, PhD, a professor of medicine and diabetes expert at the University of Missouri, Kansas City and a member of the panel.

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