April 10, 2006

US Group Says Diet Drug Linked to Pre-Cancer

By Susan Heavey

WASHINGTON -- Roche Holding AG's prescription diet drug Xenical should immediately be pulled from the U.S. market after recent data linked it to precancerous colon lesions in animal studies, a consumer group told federal health regulators on Monday.

Public Citizen, in a petition, also asked the U.S. Food and Drug Administration to reject making the weight-loss pill widely available over the counter.

On Friday, the FDA said it granted GlaxoSmithKline Plc conditional approval to sell the drug without a prescription if it first meets certain undisclosed criteria. Glaxo owns U.S. rights for nonprescription sales of Xenical.

"The failure to ban the prescription version of this drug, or worse, to make it much more widely available by allowing OTC sales is a decision that is likely to increase cancer incidence," Public Citizen wrote.

The group said a December 2005 study confirmed earlier company data showing Xenical, known generically as orlistat, can cause abnormal cell growth in the lining of the colon. Experts widely recognize the lesions as an early indicator of cancer, the advocacy group added.

The study, published in the journal Cancer Letters, found "a significant increase" of colon lesions in rats given Xenical regardless of whether they were on high-fat or standard diets.

"This finding makes it even clearer how ill-advised switching orlistat to OTC status would be," the petition said.

Representatives for the two drug makers were not immediately available to comment on the petition.

Xenical comes in 120-milligram capsules to be taken three times a day with meals. The proposed nonprescription version, called Alli, comes in 60 milligram tablets with one to two taken with meals.

It works by preventing fat from being absorbed by the body but can cause excess gas, oily discharge and other gastrointestinal problems.


Public Citizen also said its review of reported side effects after Xenical hit the market in 1999 found 28 cases of breast cancer in patients taking Xenical through June 2005.

A review of its rival, Abbott Laboratories Inc.'s appetite suppressant Meridia, found two breast cancer cases between November 1997 and June 2005.

The FDA was aware of the breast cancer risk as well as possible colon lesions when it initially considered Xenical, Public Citizen said, but the agency chose to rely on the company's analysis.

An FDA spokeswomen could not be immediately reached.

The link between fat and cancer is unclear, but some studies have shown a higher risk in people who are overweight or obese. Other studies have shown no change in risk despite lower fat diets.

Some early data have shown Xenical's key ingredient can help curb fatty acids and possibly limit tumor growth, Public Citizen said, and removing it from the market would not stop future research.

But "at this point, the evidence of orlistat's ability to cause cancer is much stronger than any potential ability to prevent it," it said.

Shares of Glaxo were up 66 cents, or 1.3 percent, at $52.14 in afternoon trade on the New York Stock Exchange after earlier closing up 1.15 percent in London. Roche shares earlier closed up 1.3 percent on the Swiss market.