Voltaren Gel Linked to Severe Liver Damage
Some patients using Voltaren Gel have developed drug-induced hepatoxicity soon after beginning treatment, prompting the drug’s maker to update the product’s labeling to indicate the risk.
The Food and Drug Administration, Novartis Consumer Health, and Endo Pharmaceuticals has notified healthcare professionals about the recent revisions to the Hepatic Events section of the Prescribing Information of Voltaren Gel to include new warnings and precautions about the risks of liver injury in patients treated with all products containing diclofenac sodium.
Pain Relief Gel Linked to Liver Damage
Voltaren Gel (diclofenac sodium topical gel 1%) is a non-steroidal anti-inflammatory drug for treatment of pain caused by osteoarthritis of joints which are suitable for use of topical treatment, such as the knees and the joints of the hands, the FDA said. The product has not been evaluated for use on joints of the spine, hip, or shoulder.
Some cases of severe hepatic reactions, including jaundice, liver necrosis, fulminant hepatitis, and liver failure have been reported in Voltaren Gel users, the FDA said. The agency did not indicate how many reports have been received, but officials said some of the reported cases have resulted in patient deaths or liver transplants.
Because of the injury reports, the FDA and Novartis are advising physicians to measure the levels of enzymes called tranaminases often in patients who are undergoing long-term diclofenac therapy, including with Voltaren Gel. Clinical trials have found the best time to take the measurements is between four to eight weeks after beginning treatment with diclofenac, the FDA said.
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