Xenical and Alli liver damage are in the news lately following an August 24th ‘Early Communication’ from the FDA regarding Xenical and liver injury. Xenical (generic drug name: orlistat) is a diet drug that, according to its manufacturer Roche Holdings, helps individuals lose and keep off excess weight by blocking the absorption of fat consumed.

Individuals who have experienced liver damage after taking Xenical or Alli can get detailed information about the FDA’s warning at Bernstein Liebhard LLP, and can get advice regarding their legal rights.

Orlistat: Xenical and Alli’s Active Ingredient

Xenical is a prescription-only drug, FDA-approved for use as a diet aid in 1999. It comes in 120-milligram doses (of the main ingredient, orlistat) taken one to three times per day. An over-the-counter (OTC) version of orlistat, Alli, was approved by the FDA in 2007. Alli comes in 60-milligram doses (half that of Xenical), also to be taken one to three times a day.

Liver Injuries and Hepatotoxicity

Xenical side effects and Alli side effects are listed on their packaging (and on the Prescribing Information for Xenical). These side effects do not describe liver damage or hepatotoxicity (toxic effects on the liver), but the FDA’s Early Communication notes that over 30 cases of liver damage among Xenical users have been reported since 1999.

Hospitalization and Liver Failure

Of the Xenical patients whose cases were reported to the FDA (there may be more, unreported incidents), 27 needed to be hospitalized, and six patients experienced liver failure — an extremely serious condition. Roche Holdings and GlaxoSmithKline (GSK), the pharmaceutical giant that makes Alli, have given additional data regarding Xenical and Alli liver damage to the FDA.

Response by GlaxoSmithKline

On September 2nd, GSK responded to the FDA’s Early Communication with its own press release (or, as they called it, a “Consumer Healthcare statement”), stating that orlistat (Alli’s active ingredient) is the most-studied weight loss “medicine” in the world, and that its safety record was established in more than 100 clinical studies. GSK noted that the FDA has not established a link between Alli and hepatotoxicity.

How Xenical and Alli Work

Orlistat attaches to some of the enzymes in a user’s digestive system and thereby keeps these enzymes from breaking down (digesting) about 25 percent of the fat that the user has eaten. The undigested fat can’t be absorbed by the body, and is eliminated.

Contact a Bernstein Liebhard attorney about Xenical, Alli and liver damage in a no-cost, confidential consultation.

Published November 17, 2011 by