Alerts
Diclofenac Topical Gel 1% (Voltaren Gel) and Hepatic Toxicity
December 7, 2009
FDA and the manufacturers of diclofenac topical gel 1% (Voltaren Gel) are warning healthcare professionals of hepatic toxicity during therapy with diclofenac products. Potentially-fatal hepatic reactions have been reported during postmarketing, including increased transaminases, hepatic necrosis, jaundice, fulminant hepatitis, hepatic failure, and death. In some cases, patients required liver transplantation for these events. Although most cases were reported during the first 1 - 2 months of diclofenac therapy, hepatic reactions may occur any time during therapy. The product labeling has been updated to include this information.
Diclofenac topical gel 1% (Voltaren Gel) is labeled for the relief of osteoarthritis pain in joints including the knees and hands. In patients receiving long-term therapy with diclofenac, the manufacturers recommend monitoring hepatic transaminases at baseline, within 4 - 8 weeks of starting therapy, and periodically. Discontinue diclofenac immediately if abnormal liver tests persist or worsen, or if the patient develops signs and symptoms of liver disease (eg, eosinophilia, nausea, fatigue, diarrhea, pruritus, rash, jaundice, dark urine, right upper quadrant tenderness, or "flu-like" symptoms). Educate patients to contact their primary caregiver if they develop any symptoms of liver disease.
Additional information is available at the following links:
- MedWatch alert::
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm - Dear Healthcare Professional Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM193101.pdf - Revised Product Label:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf
Updated
December 7, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
