diclofenac sodium topical gel: Hepatic Effects Labeling Change: Cases of drug-induced hepatotoxicity reported

Voltaren Gel (diclofenac sodium topical gel) - Hepatic Effects Labeling Change: Cases of drug-induced hepatotoxicity reported

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes
Audience: Rheumatological healthcare professionals, pharmacists
Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis 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 receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.
Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm


Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes
Audience: Rheumatological healthcare professionals, pharmacists

[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis 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 receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

[Sept 2009 - Prescribing Information - Endo]
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf

[12/04/2009 - Dear Healthcare Professional Letter - Endo, Novartis]

http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM193101.pdf