Xenical, Alli Liver Damage Side Effects Being Reviewed in Europe

European health officials have launched an investigation into the potential side effects of Xenical and Alli to determine if the risk of liver injury from the drugs outweighs the minimal weight-loss benefits provided. 

The European Medicines Agency (EMA) announced the Xenical and Alli safety review late last month, indicating that they will examine the orlistat-based medications.

The risk of liver injury from Alli and Xenical are well known, with most known cases being attributed to the more powerful prescription strength version sold as Xenical. However, the EMA will determine whether the most severe cases of liver damage affect the drugs’ benefit-risk profile.

In the United States, the FDA issued a liver injury warning concerning the drugs in May 2010 and in April of this year, a consumer watchdog group petitioned the FDA to recall Alli and Xenical from the market.

Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.

The EMA says that the most recent analysis of orlistat-based drug liver injury found 21 cases of hepatic events linked to Xenical between August 8, 2009, and January 31, 2011. Four of those cases were severe instances of liver toxicity that included one death from liver failure.

From May 2007 to January 2011, there were nine cases of suspected severe liver injury linked to Alli. However, the EMA warns that some of those cases could have other causes and noted some cases did not come with sufficient information to make a proper determination.

The EMA estimates that Xenical has been used by 38 million patients worldwide, and Alli has been used by about 11 million patients. Combined, the drugs account for 74% of weight loss drugs prescribed in England in 2009.