FDA permits obesity drug label to include studies with obese children for the first time

<br>WASHINGTON (AP) _ A label change approved Monday by the Food and Drug Administration for the first time tells doctors how an obesity drug has been successfully and effectively used by adolescents.

Tuesday, December 16th 2003, 12:00 am

By: News On 6

WASHINGTON (AP) _ A label change approved Monday by the Food and Drug Administration for the first time tells doctors how an obesity drug has been successfully and effectively used by adolescents.

The FDA approved the label change for Xenical, one of three drugs on the market that help to control weight by reducing the body's ability to digest fat from the diet.

Officials of the FDA notified Hoffman-La Roche, maker of Xenical, that the company could include in its drug label the results of two clinical drug studies that that involved children aged 12 to 16. Such information, which provides guidance to doctors, has not before been included in the label.

FDA officials said that the approved indications on Xenical's label have not been changed. Some physicians have already been prescribing Xenical for children and the information on the two studies will assist doctors in making decisions about ``off-label'' use of the drug.

One study, involving 357 teenagers who took the drug three times a day and followed a low-calorie diet, showed Xenical was more effective in reducing weight than was a placebo given to 182 patients.

The second study showed there was a decrease in iron absorption both in patients taking Xenical and in those taking placebo.

Xenical was first approved in 1999 for adult use. Studies had shown the drug helped adults lose about 13 pounds a year. Because children were not included in the early studies, the drug label gave no information on the safety and efficacy of Xenical for children. The new label now includes information from the two studies.

Xenical blocks an enzyme the body uses to digest fat. As a result, about a third of the fat consumed is excreted instead of being absorbed by the body. Side effects from the drug in some patients have included diarrhea, flatulence and fecal incontinence. These effects are more pronounced in patients who strayed from the recommended diet by eating more fat.

Since the drug blocks absorption of some fats, patients are encouraged to take daily vitamin supplements to ensure proper levels of fat-soluble vitamins A,D, E and K.