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

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.

Orlistat "is reasonably safe and certainly better than the dietary supplements that are widely advertised right now," said Alastair Wood, MD, chair of the Nonprescription Drugs Advisory Committee.

Many physicians agreed, saying this step would particularly help patients who may be hesitant to approach their doctors for assistance or whose physicians don't want to resort to such pharmaceutical tools.

"It's potentially a valuable addition for individuals trying to control their weight, because doctors are often uncomfortable prescribing obesity medications, and patients are often reluctant to ask their doctor for a medication for their weight," said Robert Kushner, MD, medical director of the Wellness Institute at Northwestern Memorial Hospital in Chicago. "This situation is much like that of smoking-cessation aids. Doctors did not prescribe much in the way of nicotine-replacement products. When they went over the counter, use when up significantly."

Those opposed to the switch expressed concern about potential abuse by people with eating disorders. Also, there was debate about a patient's ability to determine if the drug was appropriate.

According to the actual use trial considered during the meeting, about a third of people choosing the drug were not obese and nearly two-thirds had a contraindication to its use.

"Most people cannot calculate a BMI or understand who this medication is most appropriate for," said Ruth Parker, MD, a member of the committee and professor of medicine at Emory University School of Medicine in Atlanta. She voted against the recommendation. "And there's the potential that this product can be abused, particularly by teenage girls."

Some experts also expressed dismay that this drug, which is widely acknowledged to be only modestly effective over the short term, would take the focus away from lifestyle interventions that are more likely to have a long-term effect. Most studies show that when used by people also exercising and dieting, the drug results in five to six pounds of additional weight loss over a six-month period. Once the drug is stopped, the weight is regained.