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FDA OKs over-the-counter sale of diet drug

February 08, 2007|Denise Gellene and Shari Roan | Times Staff Writers

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 the drug would retail at $2 to $3 for a day's dose. The company expects 5 million to 6 million people to try the drug during its first year on the market.

Dr. Charles J. Ganley, FDA director of nonprescription products, said consumers should use the pill as part of a diet and exercise program. Used alone, it "is unlikely to be beneficial," he said at 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, those side effects also prevent people bent on losing weight from abusing alli, Youdim said.

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 used the pill must be willing to exercise and reduce their total calorie intake to see meaningful results.

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

But Steven L. Burton, Glaxo vice president for weight control products, said orlistat had 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.

"This is the most extensively studied weight loss medicine in the world," Burton said.

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

Glaxo estimated that Americans spent $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 highly successful, with U.S. sales peaking around $200 million in 2000.

Sales suffered because few insurance plans covered the drug, and obese people, the chief market for the prescription product, were not satisfied with the small amount of weight they lost.

Dr. Peter LePort, a weight loss specialist at Orange Coast Memorial Hospital in Fountain Valley, said alli would appeal to people who want to lose a modest amount of weight without 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 would boost weight loss by 50% 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 adding the drug to their regimen, Bansal said.

Bansal said that most of the weight loss took place in the first six months and that after that patients reached a plateau.

The drug works by blocking the absorption of fat -- and the calories that come with it -- in the intestine. Xenical blocks 30% of fat and alli prevents absorption of 25%, 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 the side effect.

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

"It will teach them how to eat appropriately," he said.

The FDA said people who use the drug should take a vitamin supplement because the drug also blocks absorption of some fat-soluble vitamins, including vitamin D.

The drug was not approved for people under 18, who need such nutrients to grow.

Glaxo will market the drug as part of a total weight loss program, which will include guides to healthy eating, a calorie counter and a website offering individualized plans.

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denise.gellene@latimes.com

shari.roan@latimes.com

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