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CNN's Linda Ciampa reports on the approval of Xenical
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April 26, 1999
Web posted at: 5:57 p.m. EDT (2157 GMT)

WASHINGTON (CNN) -- A diet drug that reduces fat absorption won approval Monday from the Federal Drug Administration.

Orlistat, the first of a new class of drugs called lipase inhibitors, can decrease absorption of dietary fat in the gastrointestinal tract by about 30 percent, according to drug manufacturer Roche Laboratories.

The FDA approved it by prescription for the seriously obese only -- not casual dieters who want to shed five or 10 pounds.

The drug, trade-named Xenical, was tested over seven years on more than 4,000 patients.

On average, 57 percent of patients treated with Xenical and 31 percent of placebo-treated patients lost at least 5 percent of their body weight. All patients in the studies received nutritional counseling as well.

For those taking the drug, health authorities recommend a nutritionally balanced diet with no more than 30 percent of calories from fat.

Xenical reduces absorption of some fat-soluble vitamins such as A, D, E, K and beta carotene, so users of the drug are advised to take dietary supplements.

More than 1 million people in 17 countries have taken Xenical, Roche said.

The FDA had delayed approval for more than two years due to concerns about breast cancer risks. Further study by Roche showed the drug did not increase risk of breast cancer.

In January, the results of a two-year study on the effectiveness of Xenical were released in the Journal of the American Medical Association.

The study, funded by the drug's manufacturer, found Xenical helped patients lose weight, but only about seven pounds more after two years than the patients who took a dummy pill.

The JAMA study also showed Xenical was associated with a slight reduction in cholesterol, blood pressure and glucose.

Critics stress that Xenical is not a cure-all and should be taken only by obese patients.

Side effects of Xenical include gas, diarrhea and intestinal cramping. Typically the more fat patients eat, the more effects they experience.

Orlistat is only the second diet drug (after sibutramine) to received FDA approval since 1997, when the administration banned the popular fen-phen combination after it was linked to several heart-related deaths.

Reuters contributed to this report.