Approval of orlistat capsules over-the-counter

Feb 7 2007

The U.S. 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."

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.

The most common side effect of the product is a change in bowel habits, which may include loose stools. Eating a low fat diet will reduce the likelihood of this side effect. Also, people who have had an organ transplant should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat.

FDA approved OTC orlistat based on the review of the sponsor's safety data and after submitting the product for the consideration by an FDA advisory committee in January 2006. The committee voted in favor of OTC approval.