The Therapeutic Goods Administration (TGA) has said there was no evidence of an association between Xenical (orlistat) and liver injury after its US counterpart launched an investigation into the link.
The US Food and Drug Administration (FDA) announced yesterday that it was reviewing adverse event reports of liver injury in patients taking the weight loss drug.
The FDA received 32 reports of serious liver injury in patients taking Xenical between 1999 and 2008. Of those cases, 27 reported hospitalisation and six resulted in liver failure.
The most commonly reported adverse events included jaundice, weakness, and stomach pain.
The FDA said it would review additional data submitted by the drug's manufacturers on suspected cases of liver injury.
"The FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time," the US regulator said in a statement.
A TGA spokesperson said since Xenical was registered in Australia in 1997 it had received a total of 179 adverse drug reports but there had been no reports of serious liver injury or liver failure.
"At this stage there is no evidence of a causal relationship between the use of orlistat (Xenical) and liver injury. The FDA communication is simply a notification that a potential association is to be explored," the spokesperson said.
"These announcements occur long before the FDA has made any assessment of the relationship between the medicine and the side effect observed."
The TGA said it would follow the FDA's review of the issue and consider whether any regulatory action was appropriate.
Consumers have been advised to contact a health professional if they have any concerns.
A spokesperson for Xenical maker Roche said: "Adverse event reports received by Roche of hepatic disorders have been very rare."
The spokesperson advised patients to continue using Xenical as directed.