Weight-Loss Drugs Xenical and Alli Alert

Have You Taken the Weight-Loss Drugs Xenical or Alli (Orlistat)? You May Be At Risk for Liver Failure

At least 32 people who have taken two forms of the weight-loss drug orlistat since 1999 have developed liver failure or liver disease. Alli is the brand name for the over-the-counter form of orlistat, while the prescription-strength form is sold under the brand name Xenical. The Food and Drug Administration is now formally investigating both drugs for a possible link to severe liver disease in users.

In 27 of the reported cases of injuries tied to Xenical and Alli, the patients had to be hospitalized, and in six cases, the user suffered liver failure. There were more cases linked to the use of Xenical than to Alli and most of the liver-injury cases were reported in Europe, where the drugs also are widely used.
Both Xenical and Alli are approved for use in conjunction with low-fat

and low-calorie diets to stop or reduce weight gain. Unlike most weight-loss drugs, which work by suppressing appetite or boosting metabolism, Xenical and Alli work by keeping the digestive system from absorbing dietary fat, which reduces daily caloric intake and can help limit unwanted weight gain. The drugs are seen by some as being safer than diet drugs that suppress appetite or increase metabolism, but the reports of serious liver disease are troubling.

FDA Looking Into Liver Damage Reports

In August 2009, the FDA announced it was beginning an investigation into dozens of reports of liver injuries in orlistat received from 1999 through October 2008. The FDA said its review of the reports is continuing and could end with the drugs either being ordered pulled from the market, slapped with packaging labels to warn physicians and users of the risks, and other safety measures.

Since the FDAs announcement, sales of Xenical and Alli have plummeted as women and doctors express concerns about their side effect risks. GlaxoSmithKline, the maker of Alli, has launched an extensive public-relations campaign seeking to improve the reputation of its blockbuster diet drug, but many users and their physicians have already decided that the risks associated with the drug simply are too great when compared to the relative risks of serious liver injury.