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ROCKVILLE, Md. -- The FDA today approved over-the-counter sale of a low-dose version of Xenical (orlistat), a prescription diet drug that works by blocking the absorption of fat in the intestine. The OTC version will be called Alli.
ROCKVILLE, Md., Feb.7 -- The FDA today approved over-the-counter sale of a low-dose version of Xenical (orlistat), a prescription diet drug that works by blocking the absorption of fat in the intestine.
The 60-mg capsule, to be taken up to three times a day, with each fat-containing meal, will be marketed by GlaxoSmithKline, and sold under the brand name Alli. Xenical, approved in 1999 and is indicated at 120 mg up to three times a day, will continue to be marketed as a prescription drug.
The FDA said the Alli label indications will be for use in adults ages 18 or older along with a reduced-calorie, low-fat diet, and an exercise program.
The agency approved OTC orlistat on the basis of the review of the drug-maker'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.
The FDA warned that the drug was not for use by those who have problems absorbing nutrients or for those who do not meet the National Institutes of Health definition of overweight, which is a body mass index of 27 or more.
In announcing the decision, Douglas Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research, characterized the OTC decision as a public health move aimed at the "many adverse consequences" of being overweight, including 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," he said.
Because of the possible loss of certain nutrients, it is recommended that those using orlistat should also take a multivitamin at bedtime.
The most common side effect of orlistat 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, patients 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.