With the US Food and Drug Administration (FDA) having last week increased warnings in prescribing information for the non-steroidal anti-inflammatory ‘Voltaren’ gel, due to the likelihood of adverse effects on the liver, the Australian drug regulator has also assuaged its concerns about the possibility of liver damage from the use of the Voltaren gel.

In its statement pertaining to the increased warnings about Voltaren gel (diclofenac sodium 1%), the FDA had said that going by the post-marketing reports, “cases of drug-induced ‘hepatotoxicity’ have been reported in the first month but can occur at any time during treatment with diclofenac.”

The FDA statement elaborated that there have been some reports of Voltaren-linked cases of severe hepatic reactions, including liver necrosis, liver failure, jaundice, and fulminant hepatitis with and without jaundice, with a few of the cases resulting either in fatalities or liver transplantation.

Meanwhile, the Therapeutic Goods Administration (TGA) desires the Australian indication for Voltaren to carry the assurance that liver damage, associated with the use of the gel, is minimized.

A TGA spokeswoman said that since diclofenac gel is recommended only for short term use in Australia, it was rather unlikely that its use would lead to liver problems. She added that the TGA has had “only two reports of liver problems with diclofenac gel and none in the last two years.”