Healthcare professionals have been notified by Novartis and the US Food and Drug Administration (FDA) about Voltaren Gel (diclofenac sodium gel) Prescribing Information being updated, which will now include new warnings and precautions regarding the potential of all diclofenac sodium containing products for elevation in liver function tests during treatment.

While, drug-induced hepato-toxicity has been reported in post-marketing reports during the first month of diclofenac treatment, it can occur at any time. These reports include severe hepatic reaction cases, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure, some of them resulting in fatalities or liver transplantation.

It is recommended patients receiving long-term diclofenac therapy should have their transaminases measured periodically by healthcare providers, which based on clinical trial data and post- marketing experiences should be monitored within 4 to 8-weeks after beginning treatment with diclofenac.

Voltaren Gel is used as treatment for giving relief from pain due to osteoarthritis of the joints.

However, Australia’s drug regulator has allayed concerns about possible liver damage from the use of a non-steroidal anti-inflammatory gel, following USA’s Food and Drugs Administration increased warnings in prescribing information for Voltaren gel (diclofenac sodium 1%).