Voltaren Gel Side Effects May Result in Liver Problems: FDA
Published: December 8th, 2009 • Comments: 2
The FDA has announced that it is requiring new warnings about potential side effects of Voltaren gel, an arthritis topical treatment that may cause liver damage.
On December 4, the FDA, Novartis Consumer Health and Endo Pharmaceuticals sent a letter to healthcare professionals alerting them to postmarketing reports that found that Voltaren gel has been linked to cases of drug-induced hepatoxicity that have resulted in liver damage, the need for liver transplants and death. It was unclear how many reports the FDA and manufacturers have received of Voltaren gel liver damage.
Voltaren gel (diclofenac sodium topical gel) is approved by FDA for the treatment of osteoarthritis pain in joints suitable for topical treatment, such as the hands and knees. It is a prescription non-steriodal anti-inflammatory drug (NSAID).
Also known as Solaraze, Voltaren Topical and used in the Flector Patch, Voltaren gel is also sometimes used to treat migraines, gout, and menstrual pain.
The new warning label changes indicate that the gel, and all products containing diclofenac sodium, have resulted severe hepatic reactions, including liver necrosis, jaundice, and liver failure. Symptoms began to appear in some cases within the first month of therapy.
The FDA and the manufacturers recommend that patients be given the lowest effective dose for the shortest duration possible in order to minimize the risk of liver damage. They also recommend that doctors measure transaminases periodically in patients undergoing long-term therapy with Voltaren gel. Elevated levels of transaminases can be an early indicator of future liver problems brought on by the gel.
Comment by Patricia on 4 March 2010:
My husband, George, is using Voltaren Gel every day and has been for a month or two. He says it’s a wonderful product, that it greatly reduces his pain where it’s applied. I decided to research this product and am concerned by the FDA’s letter stating that Voltaren Gel has been linked to liver damage. I printed this report out and will show it to my husband so he can, in turn, show it to his doctor so that George’s liver can be checked for damage.
Comment by Michelle on 8 March 2010:
There are absolutely ZERO reports to the FDA of liver damage with Voltaren Gel. The label was ONLY updated to bring tha label of ALL diclofenac containing products in line with the ORAL formulation. This drug is only 6% absorbed into the bloodstream relative to the oral. Drug concentration are 158 times lower than with the oral. Misinformation only serves to scare patients and is irresponsible. Check with the FDA to verify. NO reports of liver damage exist, so feel confident in your medication.