FDA advisers call pill to treat obesity too risky
GAITHERSBURG, MD. — A panel of federal health specialists dealt a surprising setback yesterday to a highly anticipated anti-obesity pill from Vivus Inc., saying the drug’s side effects outweigh its ability to help patients lose weight.
The Food and Drug Administration panel voted 10 to 6 against Vivus Inc.’s Qnexa, citing unknown safety risks of long-term use. The FDA will consider the panel’s ruling and make its own decision in coming months.
Panelists unanimously agreed the drug helps patients lose pounds, with most reporting more than 10 percent weight loss. But those benefits were outweighed by a slew of safety concerns that cropped up in company trials, including memory lapses, suicidal thoughts, heart palpitations, and birth defects.
“Some of these side effects are serious and could be life-threatening and must be weighed against a relatively modest weight loss,’’ said the panel’s chairman, Kenneth Burman of the Washington Hospital Center.
The vote deals a major blow to the Mountainview, Calif., drug maker, which is racing to market the first new US prescription weight loss drug in more than a decade.
The negative opinion also suggests a higher bar for the company’s two competitors — Arena Pharmaceuticals and Orexigen Therapeutics Inc. — which are scheduled to have their own weight loss pills reviewed later this year.