Novartis and FDA Sound Warning Regarding Voltaren Gel's Potential Hepatotoxicity

Drug maker Novartis and the US Food and Drug Administration have issued warning to healthcare professionals and medicals that prescription information of the Voltaren Gel has been updated, and now includes new warnings and precautions about "potential for elevation in liver function tests during treatment with all products containing diclofenac sodium".

In the first month of treatment with the gel, the agency has shared, there have been various post-marketing reports of "hepatotoxicity", but these can happen anytime during the course of use and should therefore be prescribed carefully.

Reports that have been shared include cases of severe "hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure", and some of these cases have reportedly led to fatalities or users requiring a liver transplant.

The FDA has urged medics to "transaminases periodically in patients receiving long-term diclofenac therapy". As per the clinical data and reports shared, these should be carefully monitored within 4-8 weeks of starting the treatment.

Voltaren Gel is widely used for relief of pain of osteoarthritis of joints which occurs as a result of tropical treatment.