TGA reviews diclofenac gel

The Therapeutic Goods Administration is reviewing warnings for diclofenac sodium gel after the US drug regulator found it may cause liver damage. The US Food and Drugs Administration (FDA) strengthened warnings for all drugs containing diclofenac sodium, including Voltaren Gel (diclofenac sodium topical gel 1%), after finding the products may have adverse effects on the liver. “The use of diclofenac may result in severe hepatic reactions including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure,” the FDA said in a statement. The updated warning follows reports of drug-induced hepatotoxicity that occurred within the first month of treatment; however, the FDA noted that adverse reactions can happen at “any time during treatment”. “Abnormalities may progress with continued therapy… [and may] result in fatalities or liver transplantation,” the FDA said. In response to the findings, a TGA spokeswoman told Rheumatology Update that the FDA alert relates to long term use and recommended that diclofenac gel be used for “short term use only” (a few days). “When used as indicated, diclofenac gel would be unlikely to cause liver problems,” she said. “The TGA has had only two reports of liver problems with diclofenac gel and none in the last 2 years.”...