Prescription Diet Drug Orlistat Approved for OTC Use

On February 7, 2007, The Food and Drug Administration (FDA) approved the diet drug orlistat for sale over-the-counter (OTC) as a weight loss aid for adults who are overweight. The OTC version of the drug, called Alli, is a lower dose than the prescription drug which is still available under the brand name Xenical. Alli (Orlistat) will be marketed for adults 18 and over. It will be manufactured by GlaxoSmithKline. It is intended as part of a weight reduction program combined with a low fat, reduced calorie diet and exercise.
In a press release by the FDA, Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research states, "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."
Orlistat works by limiting the amount of dietary fat absorbed by the digestive system. It comes in 60 mg. capsules which are taken at the beginning of breakfast, lunch and dinner, or three times a day before the main meals. Because it blocks fat absorption, meals should be lower in fat to avoid unpleasant side effects like loose stools and excess gas, bloating and cramping. The FDA recommends that people who have food absorption problems should not take Alli. It is also not meant for people who are not overweight.
The FDA also provides a consumer education pamphlet to accompany the sales for Alli, which you can also access here:
Before starting this medication it is a good idea to talk to your doctor and pharmacist about possible drug interactions and other health considerations.
Photo by Arcelia Vanasse


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