FDA gives first OK to over-counter diet drug

The Food and Drug Administration yesterday approved the first government-sanctioned weight-loss aid for over-the-counter sales.

Today’s market for weight-loss drugs is saturated with dietary supplements that do not require FDA approval. The newly approved drug, called Alli, is the only FDA-approved weight-loss product available to consumers without a prescription, and is the first clinically proven over-the-counter product that is intended to be taken as part of a comprehensive diet plan.

“Over a billion dollars is spent every year on dietary supplement products that the FDA has not approved. It is very significant that there now is a product available over the counter that is FDA approved and we know what the safety of it is,” said Curtis Rosebraugh, deputy director for the FDA’s Center for Drug Evaluation and Research.

British drug maker GlaxoSmithKline PLC said Alli helps people lose 50 percent more weight than they could by dieting alone. Alli works by blocking about 25 percent of the fat in the food a person eats.

Because of the way it works, Alli must be taken with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal. FDA officials say taking a multivitamin along with Alli enhances the drug’s benefits.

Since 1999, GlaxoSmithKline has been selling the prescription version of the drug, Orilstat, which comes in higher doses than the over-the-counter Alli. Orilstat will remain available by prescription, GlaxoSmithKline said.

Alli is expected to be available in stores nationwide this summer for $2 to $3 a day. GlaxoSmithKline estimates that 5 million to 6 million people will use the drug each year.

Nearly 60 million U.S. adults are overweight or more seriously obese, putting them at increased risk of health problems such as hypertension, diabetes and heart disease, according to the National Institutes of Health.

Studies show that a person taking Alli three times a day can lose 5 to 10 pounds over six months or, for every 5 pounds a person loses from dieting, Alli can take off 2 or 3 pounds more. Studies also show that Alli has the potential to be more effective in extremely overweight people.

“If you’re markedly overweight, you are likely to have more of a benefit from taking the drug,” said Charles Ganley, director of the FDA’s Office of Non-Prescription Products. “There will be people who don’t benefit from it.”

Public Citizen, a consumer watchdog group, criticized the FDA for approving Alli, citing concerns about the drug’s association with colon cancer.

“The Food and Drug Administration’s decision to approve, for over-the-counter use, a diet drug that clearly causes pre-cancerous lesions of the colon is the height of recklessness,” said Sidney Wolfe, director of Public Citizen’s Health Research Group.