Weight Control Drug Approved for OTC Sale
The FDA has approved a previously prescription-only weight control medicine for sale without a prescription. The prescription version, which is currently on the market, is called Xenical (orlistat). The over-the-counter (OTC) version, containing one half the dose of orlistat, will be called Alli. It will become the first prescription drug for weight control to get FDA approval in the United States as an OTC drug. Alli will be indicated for persons 18 years of age and older who are on a low-calorie diet and are involved in some type of exercise program. In fact, FDA’s director of nonprescription products has indicated that Alli is unlikely to cause weight loss if it is not also combined with diet and exercise.
Orlistat causes weight loss by decreasing the amount of fat from food that is absorbed by the body. The unabsorbed fat is passed out of the body in the stool. The passage of fat can result in diarrhea, a side effect encountered by many who have taken the prescription form of orlistat. One report indicates that Alli will come as a 60 mg capsule, which can be taken up to three times a day with each fat- containing meal.