FDA Panel Gives Blessing to New Weight-Loss Drug
If agency follows suit, lorcaserin could be first such medication approved in a decade
THURSDAY, May 10, 2012 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration on Thursday recommended approval of the weight-loss medication lorcaserin, even though concerns remain about cardiovascular side effects.
If the agency were to give the nod to the drug, lorcaserin would become the first new weight-loss pill made available to Americans in a decade. The FDA is not bound to follow the advice of its expert panels, but it typically does.
The panel of experts voted 18 to 4, with one abstention, for approval, saying the drug's benefits "outweigh the potential risks when used long term" for people battling excess weight, the Associated Press reported.
Lorcaserin has not always received such a favorable reception. According to the AP, in 2010 scientists voiced concern that the drug might come with health risks, citing tumors that had developed in animal testing involving the drug.
However, Arena Pharmaceuticals, the San Francisco-based company that makes lorcaserin, has since submitted additional data in hopes the FDA might look more favorably on the drug.
According to a review of the available research posted by FDA staff online on Tuesday, that new data suggests that lorcaserin carries only a "negligible risk" of cancer in humans, the AP said. But concerns over the potential for cardiovascular risks -- hypertension in people with diabetes, for example, or injury to heart valves -- remain.
According to the AP, lorcaserin is one of three experimental weight-loss drugs that the FDA is taking a second look at after first saying no to the medications in 2010 or early 2011 because of concerns about significant side effects.
In February, another new weight-loss drug, Qnexa, was endorsed by an FDA advisory panel. The agency is expected to make a final decision on Qnexa in July.
Find out more about healthy weight loss at the U.S. Centers for Disease Control and Prevention.