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

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"This drug is only going to be effective if it's used along with a weight-loss program," Ganley said. "That means a reduced-fat diet, decreased calories and an exercise program."

"If someone uses the drug without a weight-loss program, it's not going to be very effective," he added.

A higher dose of orlistat (120 milligram capsules) has been marketed as the prescription drug Xenical in the United States since 1999.

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While the company claims Xenical's safety has been demonstrated by nine years of worldwide use in 146 countries, the consumer-advocacy group Public Citizen last year petitioned the FDA to remove Xenical from the U.S. market.

Public Citizen contended that the higher-dose drug might increase the risk of aberrant crypt foci, which are widely believed to be precursors to colon cancer.

Late Wednesday, the advocacy group issued a statement criticizing the FDA's approval of the over-the-counter version of the drug.

"At a time when colon cancer is a leading cause of death and disease in the United States, the Food and Drug Administration's decision to approve, for over-the-counter use, a diet drug that clearly causes precancerous lesions of the colon is the height of recklessness and shows a profound lack of concern for the public's health," Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, said in the statement.

One obesity expert isn't sure the new OTC drug will be effective for most people.

"The drug is probably safe," said Dr. Raj Padwal, an assistant professor of general internal medicine at the University of Alberta. "However, I'm not sure the half-strength dosage will have much effect."

Full-strength dosage reduces weight by less than 3 kilograms (6.6 pounds), on average, Padwal said.

"People may only lose 1 to 2 kilograms (2.2 to 4.4 pounds) on this half-strength dose. Whether that is worthwhile is questionable. The occasional patient may benefit, but many patients may not. For those patients who need extra incentive to adhere to a low-fat diet, the drug may help," Padwal said.

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