The U.S. Food and Drug Administration (FDA) is studying the drug Orlistat after reports of adverse effects in patients taking the drug. Orlistat is marketed as the prescription drug Xenical and the over-the-counter medication Alli. According to the FDA website, there have been 32 reports of serious liver injury in patients taking Orlistat between 1999 and 2008. Most of these cases resulted in hospitalization and six of the cases were reported as liver failure.
Alli
The over-the-counter version of Orlistat is Alli (Orlistat 60 mg). Alli was approved by the FDA for weight loss in overweight adults in 2007. According to the official Alli website, “The active ingredient in Alli attaches to some of the natural enzymes in the digestive system, preventing them from breaking down about a quarter of the fat you eat. Undigested fat cannot be absorbed and passes through the body naturally.” Because of this effect, Alli’s side effects consist of bowel movement changes such as oily spotting, loose stools, and more frequent stools that may be hard to control.
Xenical
Xenical (Orlistat 120 mg) is the prescription form of Orlistat. This form of the drug is indicated for people who have a Body Mass Index (BMI) of 30 or greater, or have a BMI of 27 or greater and have other risk factors, such as heart disease, high blood pressure, diabetes, or high cholesterol. Xenical was approved by the FDA as a prescription product in 1999 and is said to eliminate one-third of the fat in foods that is eaten by preventing it from being absorbed by the body. According to the manufacturer, the side effects of Xencial include “gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them, particularly after meals containing higher amounts of fat than are recommended.”
Both Alli and Xenical are supposed to be used in conjunction with a nutritionally balanced diet of no more than 30% calories from fat. Daily exercise is also recommended.
How to Report Problems with Alli and Xenical
The FDA is also reviewing other suspected cases of liver injury from the manufacturer of Orlistat. This is an ongoing review so no definite connection has been found between the liver problems and the drug at this time, however, consumers and their doctors are advised to report any side effects from the use of the drug to the FDA’s MedWatch Adverse Event Reporting Program.
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