Diclofenac Sodium topical gel 1% - Hepatic Effect (Liver).
Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warning and precautions about the potential for elevation in liver function tests during treatment with all products containing Diclofenac Sodium
In post marketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during the treatment with diclofenac. Post marketing surveillance has reported cases of severe hepatic reactions including liver necrosis, jaundice, fulminant hepatits with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
Physicians should measure transaminases periodically in patients recieving long-term therapy with Diclofenac. The optimum times for making the first and subsequent transaminases measurement are not known. Based on clinical trial data and post marketing experiences, transaminases should be monitored within 4 to 8 weeks after intiating treatment with Diclofenac.