FDA Approves First OTC Weight-Loss Drug

The U.S. Food and Drug Administration, for the first time, has approved a drug as an over-the-counter weight-loss medication.

The FDA says GlaxoSmithKline’s orlistat was initially approved as a prescription drug to treat obesity in 1999 and will continue to be available by prescription under the brand name Xenical in 120 milligram capsules. The newly approved 60 mg OTC capsules will be sold under the brand name Alli (AL-eye) for use by people 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 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.

The FDA said orlistat helps produce weight loss by decreasing the intestinal absorption of fat. The FDA says the 60mg capsule can be taken up to three times daily with each fat-containing meal.