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OTC weight drug seen unsafe for some: US FDA staff

Posted on: Friday, 20 January 2006, 17:32 CST

By Susan Heavey

WASHINGTON (Reuters) - A proposed over-the-counter version of the diet drug Xenical may pose safety problems for some patients, U.S. Food and Drug Administration staff said in documents released on Friday.

An FDA advisory panel of outside experts is due to meet on Monday to consider GlaxoSmithKline's petition to sell a half-dose version of Xenical without a prescription.

If the agency ultimately approves the drug, it would be the only FDA-endorsed weight-loss drug available over-the-counter. The FDA usually follows the advice of its advisory panels.

In documents released ahead of the advisory panel, FDA staff reviewers said early data showed some diabetics and other patients who are not supposed to take the drug did not understand the risk after reading the label.

"Preliminary evidence suggests that nonprescription labeling may not adequately direct the safe use of orlistat (Xenical)," the staff wrote.

Still, the FDA reviewers said the new version helped more patients lose weight after six months than those on placebo.

Known generically as orlistat, Xenical helps prevent fat from being absorbed by the body but can cause excess gas and oily discharge.

Glaxo, which bought U.S. rights for nonprescription Xenical from Roche Holding AG last year, said the nonprescription sales would help fight soaring obesity rates in the United States, making it easier for overweight Americans to seek treatment.

"OTC orlistat, in conjunction with the behavioral support program and in-pack materials, will serve as a weight loss program," the British drug maker said in documents also released on Friday, adding that gastrointestinal problems could be managed by eating less fat.

Xenical is one of two main prescription obesity drugs on the U.S market. Its rival, Abbott Laboratories Inc's Meridia, suppresses appetite.

Some analysts have said side effects already keep prescription Xenical sales low, about $460 million worldwide in 2004.

But Ira Loss, a health care analyst for Washington Analysis Corp., said the U.S. market is ripe for an easy-to-buy, effective weight loss drug.

About 65 percent of Americans are overweight or obese, government data shows.

"I think every person in America who wants to lose weight and won't go to the doctor or pay $100 to get a prescription is going to think about giving it a try," said Loss. "It's going to be big."

The 60-milligram dose should also curb side effects seen with the 120-milligram prescription version, he said.

It will also cost less, Glaxo spokeswoman Malesia Dunn said, about 60 cents per pill. Regular Xenical sells for about $1 to $2 a pill. Both must be taken three times a day.

Despite the benefits, FDA reviewers noted people regain weight when they stop using the drug.

They also worried that people may not be able to tell whether non-prescription Xenical was safe for them.

Among diabetics taking medication for their condition, 35 percent correctly recognized after reading the label that they should not take Xenical. Half of patients taking blood thinner warfarin or cyclosporine, which prevents organ rejection, realized they should not take the drug, the staff said.

Xenical can also lead to hepatitis, gallstones and kidney stones. FDA staff said the cause was unclear.

Shares of Glaxo closed down 60 cents, or 1.18 percent, to $50.15 on the New York Stock Exchange. In London, Glaxo shares closed down less than one percent.

Source: REUTERS

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