FDA OKs 1st Over-the-Counter Weight-Loss Drug

Alli only works when used with a diet and exercise program

By Steven Reinberg
HealthDay Reporter

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WEDNESDAY, Feb. 7 (HealthDay News) -- The first nonprescription drug to treat obesity in American adults was approved Wednesday by the U.S. Food and Drug Administration.

The drug, called alli (orlistat), is designed to be used only in tandem with a reduced-calorie, low-fat diet by overweight adults aged 18 and older. According to manufacturer GlaxoSmithKline, the drug helps people lose 50 percent more weight than dieting alone, should cost consumers $12 to $25 a week, and is expected to be available by this summer.

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"This is the only FDA-approved, over-the-counter weight-loss drug product," Dr. Charles J. Ganley, the FDA's director of the Division of Over-The-Counter Drug Products, said during a teleconference. "There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, although they are permitted to make these claims."

The drug will be available in 60 milligram capsules, to be taken three times a day with meals that contain fat. The company said the drug works by "blocking about 25 percent of the fat in food a person eats. Because of the way it works, alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal."

Eating a meal with too much fat while taking the drug can result in bowel changes such as loose stools, according to the FDA. These side effects typically occur in the first weeks of treatment, they aren't harmful, and can be managed by following the recommended diet of about 15 grams of fat per meal, GlaxoSmithKline said.

It's also recommended that users take a multivitamin once a day, at bedtime, because the drug can interfere with the absorption of some vitamins, GlaxoSmithKline said.

People who have had an organ transplant shouldn't take the drug. And anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using the drug, the FDA said.

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