The FDA Endocrinologic & Metabolic Drugs Advisory Committee has now recommended against allowing two new anti-obesity prescription drugs onto the market, in spite of the pervasive obesity epidemic in this country. The latest drug under consideration, lorcaserin — a novel drug that targets a specific class of serotonin receptors to suppress appetite — was rejected yesterday in a 9-5 vote. The LA Times reports panel members believed the drug’s risks outweighed the potential benefit of only a modest weight loss. Studies in animals showed the drug was associated with tumors, although an increased cancer risk has not been seen in human clinical trials.
On Wednesday, the panel recommended that a similar drug, Meridia, either be taken off the market or be limited to patients without a history or risk of cardiovascular disease, which previous studies correlate with the drug. The panel has also advised against Vivus’ Qnexa, which combines the appetite suppressant phentermine and the anticonvulsant topiramate. While the FDA does not have to carry out the advisory panel’s recommendations, it often does. “The only other weight-loss drug on the market is Xenical, available over-the-counter as Alli. Both the prescription and OTC version of these drug partially block the absorption of dietary fat,” noted ACSH’s Dr. Elizabeth Whelan.
“It is unfortunate that the advisory panel seems to be tacking towards the conservative risk side as opposed to the benefits side,” laments ACSH's Dr. Gilbert Ross, adding that “the obesity epidemic is quite serious, whether it’s increasing, decreasing or remaining the same. We believe medications can be one part of the battle against obesity. Of course, they have to be proven safe and effective.”
