Xenical/Alli Under FDA Investigation After Patient Complaints

C. Todd Alley

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The FDA has begun investigating a potential link between liver damage and Orlistat (obesity drugs marketed as Xenical and Alli). On Monday, the FDA issued an Early Communication report to alert consumers and medical providers about a potential link between Orlistat and liver damage, particularly weakness or fatigue, fever, jaundice or brown urine.

Xenical is a prescription weight-loss drug marketed by Roche Applied Science. Alli is the popular over-the-counter (OTC) version of Xenical, marketed by GlaxoSmithKline, and is the first OTC weight loss pill to be approved by the FDA. These two drugs work by preventing the intestines from absorbing fatty acids. As a result, fats are not digested and the patient’s bowel movements are disrupted, leading to gas with oily discharge, increased bowel movements, and inability to control bowel movements. These side effects are amplified after eating meals containing large amounts of fat. Effectively, both these drugs work by forcing the patient to switch to a low-fat diet and trim fats, or face the uncomfortable and embarrassing consequences.

At this point, it’s too early to conclusively link Alli or Xenical to liver damage or disease, but the FDA has found enough merit behind these complaints to investigate further. The next step will be to wait for the final FDA investigational report and recommendations. If you or a loved one are taking Xenical or Alli, and have experienced any of the liver-related side effects mentioned, you should report side effects to your medical provider and to the FDA's MedWatch Adverse Event Reporting program.