FDA Approves Orlistat - but warns that exercise must accompany its use

The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat 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."

"This drug is only going to be effective if it's used in conjunction with a weight loss program -- and what that means is a reduced-fat diet, decreased calories, and an exercise program," said Charles Ganley, MD, of the FDA's Office of Nonprescription Products in a news conference. "If someone just chooses to use orlistat alone -- without undertaking a weight loss program -- then this drug is not going to be very effective."

The product's most common side effect is a change in bowel habits, which may include loose stools. The FDA suggests a low-fat diet would lower the risk of such side effects.

GlaxoSmithKline, maker of orlistat, says It will be available this summer