FDA approves non-Rx diet pill

The Food and Drug Administration on Wednesday approved the first diet drug to be sold without a prescription.

The drug is a lower-dose version of the prescription medicine Xenical, and will become available to consumers this summer under the name “alli.”

The pill will be marketed to people over 18 and will compete against nutritional supplements, which do not require FDA approval and the rigorous safety and efficacy testing that entails.

GlaxoSmithKline, the marketer of alli, said it planned to sell the drug for $2 to $3 a day. The company expected 5 million to 6 million people to try the drug during its first year on the market.

Dr. Charles Ganley, FDA director of nonprescription products, said consumers should use the pill as part of a diet and exercise program. Used alone, the pill “is unlikely to be beneficial,” he said during a news briefing.

Dr. Adrienne Youdim, a weight loss specialist at Cedars Sinai Medical Center, said alli, also known by its generic name orlistat, has a good safety record and has helped people lose an average of 10 to 16 pounds.

The chief drawback of the pill, Youdim said, is that it can cause flatulence and greasy stools. However, Youdim said those side effects are not all bad because they prevent people bent on losing weight from abusing alli.

Madelyn Fernstrom, a weight loss specialist at the University of Pittsburgh Medical Center, cautioned that alli was not a magic bullet. “Just because it’s FDA approved for over-the-counter weight control doesn’t mean it is going to work for everybody,” she said.

Fernstrom said people who use the pill must be willing to exercise and reduce their calorie intake to see meaningful results.

Dr. Sidney Wolfe, director of health research at the watchdog group Public Citizen, said the drug can cause precancerous lesions of the colon, and the FDA should not have cleared it for nonprescription use.

But Steve Burton, Glaxo vice president for weight control products, said orlistat has been tested in 30,000 patients in 100 clinical trials for up to four years “with no cause for concern.” The FDA’s approval of alli is another sign that the drug is safe, he said.

The approval of alli comes amid increasing concerns about obesity. About 130 million Americans are considered overweight, and nearly 50 percent of them are obese.

Glaxo estimated that Americans spend $23 billion annually on weight-loss products, including $1 billion on nutritional supplements.

Alli will be available at half the strength of Xenical, but will have a similar effect on weight loss, according to the company.

Xenical was approved for sale as a prescription drug in 1999, but it was not a very successful product, with U.S. sales peaking at around $200 million in 2000.

Dr. Peter LePort, a weight loss specialist at Orange Coast Memorial Hospital in Fountain Valley, Calif., said the drug would appeal to people who want to lose a modest amount of weight without the hassle of going to a doctor for a prescription.

“There is a whole segment of society looking to lose 10 to 20 pounds,” he said.

Vichu Bansal, Glaxo director of medical affairs, said the drug will boost weight loss by 50 percent for people who make diet and lifestyle changes. That means a person who can lose 10 pounds by making dietary changes can lose 15 pounds by taking the drug too, Bansal said.

The drug works by blocking the absorption of fat – and the calories that come with it – in the intestine. Xenical blocks 30 percent of fat and alli prevents absorption of 25 percent of fat, according to the FDA.

In a 3,000-calorie-a-day diet with about 100 grams of fat, the drug would eliminate about 225 calories.

The passage of fat through the digestive system causes the drug’s gastrointestinal side effects, including diarrhea. The drug is taken at mealtimes. The FDA said that eating a low-fat diet containing no more than 15 grams of fat per meal would reduce the risk of side effects.

James Hill, a weight loss specialist at the University of Colorado, said the side effect would teach people who use the drug to cut fat from their diets, thus encouraging them to make better food choices.

The FDA said that people who use the drug should take a vitamin supplement because the drug also blocks the absorption some fat-soluble vitamins, including vitamin D. The drug was not approved for people under 18 who need such nutrients to grow.