New version of diet drug not suitable for some

Jan 23 2006

According to the U.S. Food and Drug Administration a version of the diet drug Xenical, which will be available without a prescription, may be not be suitable for some people.

Apparently initial data has revealed that diabetics and others for whom the drug is not safe, fail to understand the risk even after reading the label.

An FDA advisory panel of outside experts meets early this week to consider GlaxoSmithKline's petition to sell a half-dose version of Xenical without a prescription.

Should that endorsement from the FDA be forthcoming, the drug, will be the only FDA-endorsed weight-loss drug available over-the-counter.

As a rule the FDA usually follows the advice of its advisory panels, however FDA staff reviewers say documents released ahead of the advisory panel, show some diabetics and other patients who are not supposed to take the drug did not understand the risk after reading the label.

They did however admit that the new version of Xenical helped more patients lose weight after six months than those on placebo.

Generically known as as Orlistat, Xenical helps prevent fat from being absorbed by the body but can apparently cause excess gas and an oily discharge.

Glaxo says the nonprescription sales would help fight the soaring obesity rates in the United States, making it easier for overweight Americans to seek treatment.

The British drug maker says, used along with a behavioral support program and other support material it will present a weight loss program.

Xenical is one of the two main prescription obesity drugs on the U.S. market.

Drug company Abbott's Meridia, works by suppressing the appetite.

However analysts have said side effects already keep prescription Xenical sales low, but agree that there is a market waiting for an easy-to-buy, effective weight loss drug.

U.S. government data shows that as many as 65 percent of Americans are overweight or obese.

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

The new Xenical will cost less, 60 cents per pill, and the 60-milligram dose should also curb side effects seen with the 120-milligram prescription version which sells for about $1 to $2 per pill.

The pills must be taken three times a day.

The FDA reviewers have noted that people regain weight when they stop using the drug, and despite the benefits it is a concern that people may not be able to tell whether non-prescription Xenical was safe for them.

It appears that among diabetics taking medication for their condition, 35 percent correctly recognized after reading the label that they should not take Xenical.

While fifty percent of patients taking the blood thinners Warfarin or Cyclosporine, which prevents organ rejection, realized they should not take the drug, say the reviewers.

Apparently Xenical can also lead to hepatitis, gallstones and kidney stones.