Obesity medicine orlistat linked to liver toxicity
4 October 2011
The anti-obesity medicine orlistat, sold in Australia by pharmacists as Xenical, is again under a cloud following concerns raised in Europe linking it to liver injury.
The European Medicines Agency (EMA) said it had found 4 people with severe liver toxicity linked to orlistat 120 milligram capsules in 2 years, including one who died of liver failure and another who required a liver transplant. There were another 9 severe cases of liver injury with suspected links to orlistat 60 milligram capsules (EMA, online 22 Sep 2011).
A spokesperson for the Therapeutic Goods Administration (TGA), the government body that regulates medicines in Australia, said the events would be reviewed.
To date 182 reports associated with adverse events (side effects) to Xenical, including 3 non-serious liver-related events, had been received.
The manufacturer, Roche, said the medicine's safety had been demonstrated in more than 100 clinical studies involving 30,000 patients.
The liver toxicity issue had been reviewed only last year and no changes to the product information were required by the TGA, the company said.
Last Reviewed: 07 October 2011
- 1. European Medicines Agency. European Medicines Agency starts review of orlistat-containing medicines (22 Sep 2011). http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001345.jsp (accessed Oct 2011).
