Fat-blocking pill will be sold over the counter

FDA allows nonprescription sale of lower-dose version of Xenical

WASHINGTON - Dieters got a new tool Wednesday to help them take off the extra pounds — the first government-approved nonprescription diet pill.

The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.

The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.

Dr. Charles Ganley, FDA’s director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.

“Using this drug alone is unlikely to be beneficial,” Ganley said at a telebriefing. ...

Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.

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"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health." link

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The way orlistat works to prevent weight gain or promote weight loss is to inhibit enzymes that would otherwise facilitate absorption of fat in the gastrointestinal duct. As reported, the drug can stop as much as 20 to 30 percent of dietary fat from being absorbed.

Because fat-soluble nutrients need fat as carrier to get into human body, the diet drug inevitably blocks absorption of fat-soluble vitamins such as vitamin D, K, E, and other fat soluble nutrients. For this reason, the consumers of orlistat are suggested to take a multivitamins at bedtime to compensate the loss of nutrients due to the use of the diet drug.

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The worse part is this: studies showed the weight loss effect diminished and lost weight came back after use of the drug was discontinued. Those who want to keep the pounds off need to keep taking the pill. But that is not advisable because the long term adverse effects of this diet drug remain unknown.

Considering the fact that the drug prevents absorption of fat-soluble nutrients, potentially leading to malnutrition, it is unreasonable for one to continue the dieting regimen beyond six months. What does that mean is, you may have to lose the regained weight again later.

The side-effects of using orlistat, prescription or TOC, include gas with discharge, oily discharge, increased number of bowel movements, oily spotting, oily or fatty stools, urgent need to have a bowel movement and inability to control bowel movements. About 50 percent of patients on the drug experienced some side-effects and seven percent lost bowel control. For this reason, one may have to take another drug to get the side-effect under control. link at foodconsumer.org