OTC Weight Loss Drug Approved by the FDA

FDA Approves Orlistat for Over-the-Counter Use

The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat (Xenical) was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version. OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program .

"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 for 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."

OTC orlistat is not for people who have problems absorbing food or for those who are not overweight. "Overweight" is defined by the National Institutes of Health as having a body mass index (BMI) of 27 kg/m2 or more. Orlistat helps produce weight loss by decreasing the intestinal absorption of fat. The 60 mg capsule can be taken up to three times a day with each fat-containing meal. Because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin at bedtime.