Update: Xenical, alli (Orlistat)

Safety warnings | messages in brief | 17/02/2012

The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults who are overweight (body mass index BMI > = 28 kg/m2 in conjunction with a slightly hypocaloric, low-fat diet.

Measures at EU level

The risk of liver reactions associated with the use of orlistat 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 lists adverse reactions such as hepatitis, cholelithiasis, and liver enzyme elevation.

For orlistat 120 mg, the most recent analysis for the period from 1997 to 2011 showed a total number of 21 reports of the occurrence of serious liver reactions; for orlistat 60 mg, a total of nine cases have been reported since 2007. The total number of case reports must be viewed in the context of cumulative use in 53 million patients worldwide, including 20 million in Europe.

The completed evaluation was conducted under an Article 20 procedure at the initiative of the European Commission, with the CHMP assessing all available data from clinical trials, publications, and post-marketing surveillance. This showed no evidence of a plausible hepatotoxic pathomechanism, nor did the case reports show a consistent pattern. The number of reports is very low compared to the extent of use and is below the expected background incidence. Furthermore, obesity itself is considered a risk factor for the occurrence of liver disease.

The CHMP concluded that the risk-benefit balance for orlistat-containing proprietary medicinal products remains to be considered positive. The SmPCs of the preparations will be harmonized to ensure that they contain the same information regarding liver reactions.

Situation in Austria

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

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

The BASG 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 advised to follow the recommendations in the current SmPC.

Further information:

European Medicines Agency press release, Feb. 16, 2012.




Further inquiry note