Xenical under review as liver toxicity link found

THE anti-obesity drug orlistat, sold over the counter in Australia as Xenical (Roche), is again under a cloud following concerns raised in Europe linking it to liver toxicity.

The European Medicines Agency (EMA) said last week it had found four severe cases of liver toxicity linked to orlistat 120 mg in two years, and another nine reported cases of severe liver injury with orlistat 60 mg. 

A TGA spokesperson said the events would be reviewed. 

To date 182 reports associated with adverse events to Xenical, including three non-serious liver-related events, had been received.

Roche said the drug’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 PI were required by the TGA, the company said.