Safety Alerts & Recalls

What does this mean?

A cause-and-effect relationship of severe liver injury with orlistat use has not been established. However, because of the seriousness of this possible side effect, the FDA has revised the drug labels for Xenical and Alli to inform patients and healthcare professionals about this new safety information.

If you are experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools while taking Xenical or Alli, please contact your doctor or other healthcare professional immediately. These may be signs of liver injury.

If you have any concerns about your treatment with Xenical or Alli, please talk to your doctor or other healthcare professional.

FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury

According to the U.S. Food and Drug Administration (FDA), people who take Xenical or Alli need to be aware of the rare occurrence of severe liver injury reported in some individuals who take these weight-loss drugs. The active ingredient in both of these drugs is orlistat. Xenical (orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over-the-counter (OTC) without a prescription.

The FDA has approved a revised label for Xenical to include this new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The FDA is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning.

For more information form the FDA about orlistat and severe liver injury, please visit: FDA's Consumer Update - more information here

FDA's Questions and Answers - more information here

FDA's Complete Safety Announcement - more information here

Source: FDA
Publication Date: 2010-05-27
Last Updated: 2010-05-28

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