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FDA Panel Gives Nod to OTC Orlistat

Bruce Goldfarb

An advisory committee recommended that the Food and Drug Administration (FDA) grant marketing approval for 60 mg capsules of orlistat for over-the-counter (OTC) use.

After a day of presentations, the drug was recommended for approval in an 11–3 vote on January 23 by the joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee.

FDA usually follows the advice of its advisory committees, with decisions coming about 6 months after advisory committee meetings. If all goes according to the sponsors' plans, the drug would be the first FDA-approved weight-loss medication sold without a prescription.

Manufactured by Roche and co-promoted in the U.S. by GlaxoSmithKline Consumer Healthcare, orlistat will remain available by prescription in 120 mg capsules as Xenical. Glaxo proposes to market the OTC version of the drug as Alli—pronounced AL-eye.

Alli would be indicated for use by overweight adults along with a reduced-calorie, low-fat diet. Glaxo says the company will provide information and advice on how to follow a healthy eating plan.

Orlistat is a reversible inhibitor of lipase that works in the gastrointestinal tract with virtually no systemic effects. The drug blocks the body's absorption of dietary fat by about 30%.

Weight-loss experts met the news with guardedly positive comments. "Orlistat is a good drug," says Michael Steelman, MD, chairman of the board of the American Society of Bariatric Physicians (ASBP). "In a physician's hands, it is safe and effective. But I have some reservations about the drug going over-the-counter."

PATIENTS SHOULD BE EVALUATED BEFORE TAKING ORLISTAT, WHETHER PRESCRIPTION OR OVER-THE-COUNTER.

SAFETY PROFILE

Although orlistat has a good safety profile, the drug can interfere with the blood-thinning drug warfarin (Coumadin, Bristol-Myers Squibb/Marevan, Glaxo Wellcome) and the immunosuppressant cyclosporine (multiple brands and manufacturers), and can reduce the body's absorption of fat-soluble vitamins such as A, D, E, and K. Glaxo says it will include a coupon for multivitamins in each package, but rejected the idea of adding vitamins to the product.

ASBP president Mary Vernon, MD, says patients are unlikely to abuse orlistat or take it in amounts larger than recommended, as the drug can cause bloating, abdominal distress, diarrhea, and oily leakage. "The side effects are unpleasant and socially unacceptable," Vernon says.

A greater concern is that, without proper counseling and management from a health professional, a person may fail to lose weight on OTC orlistat and abandon weight-loss efforts.

Steelman says before taking orlistat—or adopting any weight-loss strategy—patients should see their physician to make sure they are screened appropriately for pertinent health issues.

"People who have a serious weight problem should be evaluated by a physician before taking orlistat, whether prescription or over-the-counter," he says.

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