HEALTH

FDA panels recommend that weight-loss pill go over the counter

The possibility of a well-regulated alternative to dietary supplements is welcomed by some, but critics say the drug may be abused.

By Victoria Stagg Elliott, AMNews staff. Feb. 20, 2006.

Two Food and Drug Administration advisory committees recommended last month that a lower-dose version of a prescription weight-loss drug be made available over the counter.

The Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of the agency giving GlaxoSmithKline a green light to market Alli, a 60 mg version of orlistat, accompanied by information about healthy eating and other lifestyle changes necessary to lose weight. Prescription-strength orlistat, marketed as Xenical, is 120 mg.

"We are excited by the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss. Alli will be more than a pill. It will be a program that will help people lose weight, adopt a healthy eating plan and make other lifestyle changes," said George Quesnelle, president of GSK Consumer Healthcare North America.

The FDA is not obligated to follow the recommendations of its committees but usually does.

This possible shift has been greeted with both praise and trepidation.

Those at the meeting in favor argued it would make a safe drug more widely accessible to the many people who need to lose weight. Also, as potentially the only FDA-approved weight-loss drug available OTC, it would provide a valuable alternative to the dietary supplements so many people turn to, even though these are not as well-regulated and may not have as much safety data.

[...]

Full text of AMNews content is available to AMA members and paid subscribers.

Access details

Join the AMA