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FDA approves over-the-counter orlistat for weight loss
The drug is the only FDA-approved weight loss pill available without a prescription.
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Americans will soon have a new weight loss option available on the market.
The FDA has announced the approval of orlistat (Alli, GlaxoSmithKline) 60-mg capsules, for over-the-counter use in the United States. Orlistat is now the only FDA-approved weight loss pill available to consumers without a prescription.
The pharmaceutical company promises an added 50% reduction in weight compared with diet or exercise alone for the OTC drug, which works by blocking 25% of the fat contained in food.
However, simply taking this pill will not guarantee weight loss, and a change in eating habits will be required for weight loss, researchers said.
“It is about losing weight the right way,” Caroline Apovian, MD, director of the Center for Nutrition and Weight Management, Boston Medical Center, said during a teleconference in February.
The pill is indicated for use in conjunction with a reduced-calorie, low-fat diet in overweight adults 18 years of age and older. Individuals are recommended to take one pill three times a day with meals that contain no more than about 15 g of fat each.
Along with the pill, consumers will receive seven pocket-sized reference guides designed to help make healthy meal choices and encourage physical activity. Advice and support will also be available online at www.myalli.com, according to GlaxoSmithKline.
Orlistat is not new to the diet drug marketplace. It has been sold by prescription as Xenical 120-mg capsules (Roche Pharmaceuticals) since 1999 and will still be available by prescription when Alli hits the market this summer.
The most common adverse event is bowel changes, including loose stools, frequent stools that may be difficult to control and gas with oily spotting. According to experts, these risks may be reduced in patients who sustain a low-fat diet while taking alli. These events typically occur during the beginning of treatment with alli, but may continue. – by Katie Kalvaitis