TOS Asks FDA Panel to Consider the Need for Obesity Treatments: FDA Panel Gives Treatments Mixed Reviews

Advocacy

TOS Urges FDA to be Fair when Judging New Evidence-Based Treatment Approaches for Obesity

On September 15 and 16, 2010, the Food & Drug Administration (FDA) and its Advisory Committee on Endocrinologic and Metabolic Drugs met to review the use of sibutramine and lorcaserin in the treatment of obesity. The Obesity Society (TOS) urged the panel to consider the need for safe and effective treatments in reviewing both of the drugs.  In the case of sibutramine, the panel was evenly divided (8-8) on whether to allow sibutramine to remain on the market. For lorcaserin, the panel voted 9-5 to ask the sponsor, Arena Pharmaceuticals, to provide additional data before approving the drug.

The focus of the September 15 advisory committee meeting was new safety data on sibutramine, a treatment that has been marketed for obesity treatment since 1997. New data from the SCOUT trial, recently published in the New England Journal of Medicine was the focus of the review. The authors of the study concluded that “Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause.” Sibutramine is contraindicated for use in patients with pre-existing cardiovascular disease. The panel was unanimous in calling for stronger warnings in the label for sibutramine. Theodore Kyle, RPh, and chair of the TOS Advocacy Task Force, presented a statement on behalf of TOS, urging the panel to balance the need for effective treatments with the need to protect patients who are poor candidates for treatment with sibutramine.

The focus of the September 16 hearing was a new agent for the obesity treatment, lorcaserin (Lorqess®). After a day-long review of safety and efficacy, the majority of panel voted to require additional data before approving  the drug. "I think the drug is promising, it's just not quite there yet," said Edward W. Gregg, MD, chief of the Epidemiology and Statistics Branch at the CDC and a member of the panel. Past TOS President, George Bray, MD, presented a statement on behalf of TOS, urging the FDA to help in finding safe and effective medications for obesity management.

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