Orlistat Gets Over-the-Counter Approval from FDA
THURSDAY, Feb. 8 (HealthDay News) -- The U.S. Food and Drug Administration has approved the adult weight-loss aid orlistat for over-the-counter (OTC) sale, although higher doses of the drug will still require a prescription. The drug came onto the market in 1999. The OTC capsules will be manufactured by GlaxoSmithKline and marketed under the name Alli.
The drug is unsuitable for people who are not overweight by National Institutes of Health standards, which defines overweight as a body mass index of at least 27 kg/m2. It is also unsuitable for people who have difficulties with food absorption, may be at risk of drug interactions due to organ transplantation, are taking blood-thinning drugs and those with diabetes or thyroid disease.
The OTC version contains 60 mg of orlistat and can be taken up to three times a day with a fat-containing meal. Because the drug works by blocking absorption of fat, one of the common side effects is loose stools, as well as blocking absorption of some nutrients.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes. OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," said Douglas Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research, in a statement.
