Xenical, Alli (Orlistat)

Safety warnings | messages in brief | 23/09/2011

The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults with overweight (body mass index BMI≥28 kg/m2 in combination with a mildly hypocaloric, low-fat diet. The European Medicines Agency (EMA) has started to review the risk-benefit balance of all orlistat-containing proprietary medicinal products with regard to the risk of occurrence of liver injury.

Action at EU level

The risk associated with the use of orlistat for the occurrence of liver reaction is well known and has been under careful monitoring by the Committee for Medicinal Products for Human Use (CHMP) since approval. The current SmPC already reflects this risk, which is furthermore addressed in the Risk Management Plan. The vast majority of liver reactions are mild, with severe reactions reported very rarely. The focus of the recent review is on the significance of these serious reactions for the risk-benefit balance: for orlistat 120 mg, the most recent analysis for the period from 1997 to 2011 showed a total of 21 reports of the occurrence of serious liver reactions, to be assessed in the context of cumulative use in 38 million patients. For orlistat 60 mg, there are a total of nine case reports for the period from 2007 to 2011, in which case the cumulative use was 11 million patients. The CHMP will review the available relevant data on the hepatotoxic risk of orlistat and subsequently decide on the need for regulatory action. Situation in Austria

The following orlistat-containing medicinal products are approved in Austria:

  • Xenical 120 mg hard capsules
  • alli (orlistat) 120 mg hard capsules
  • alli 60 mg hard capsules

BASG/AGES PharmMed has received a total of five reports of adverse effects associated with Xenical and Alli, none of which involved liver reactions.

Recommendations of the BASG

  • Prescribers are urged to follow the recommendations of the current SmPC.
  • Pharmacists are urged to follow in particular the current dispensing instructions for the product available without prescription.
  • Patients are urged to follow the current directions for use.

Further information:

European Medicines Agency press release (Sept. 22, 2011).



Further inquiry note