FDA panel rejects experimental weight loss drug on cognitive side effects

Thursday, July 15, 2010

FDA panel narrowly sides against weight loss pill

GAITHERSBURG, MD. — A Food and Drug Administration panel has voted 9-7 against Vivus Inc.’s Qnexa citing the experimental obesity treatment’s negative side effects.

Federal health advisers say the negative effects on concentration and memory outweigh its ability to help patients lose weight.

The vote deals a major setback to the Mountainview, Calif., drugmaker which is racing two other small California drugmakers to market its weight-loss pill.

The FDA will consider the panel’s recommendation and make a final decision later this year.

The agency has not approved a new prescription weight loss pill in over a decade, and currently available drugs have limited effectiveness and worrisome side effects.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP’s earlier story is below.

GAITHERSBURG, MD. (AP) — Federal health experts say they have concerns about a highly anticipated weight loss drug’s side effects on memory and concentration.

The panel of Food and Drug Administration advisers is scheduled to vote later this afternoon on whether to recommend approval for Vivus Inc.’s drug Qnexa.

The agency does not have to follow the group’s advice, though it often does.

Studies of Qnexa show the drug causes significant weight loss, with most patients losing more than ten percent of their weight. But patients also reported memory and attention lapses and trouble finding words.

The Mountain View, Calif., drugmaker is racing two other small California pharmaceutical companies to bring its weight-loss drug to the market.

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