12/15/09 A federal agency has announced new warnings for all products containing diclofenac sodium, including Voltaren Gel, because the medications have been linked to reports of serious liver damage resulting in transplants and deaths.

Voltaren is a non-steroidal anti-inflammatory drug, or NSAID, which is typically prescribed for osteoarthritis pain.

Many favor Voltaren Gel over pills because it is thought to be less likely to cause stomach irritation and bleeding, and it has been lauded as a safer pain reliever, particularly for elderly patients.

But after reports of liver toxicity were linked to Voltaren, officials with the U.S. Food and Drug Administration (FDA), are urging doctors to closely monitor levels of liver enzymes called transaminases in patients who use the gel.

Transaminase levels are measured by a blood test, and the FDA recommends testing four to eight weeks after starting the gel.

“Post-marketing 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,” according to an FDA statement.

The FDA said borderline or greater elevations in liver injury tests occurred in 15 percent of Voltaren-treated patients, sometimes as early as the first month of use.

“The warning recently announced was a labeling change applied to all products that contain diclofenac, the active ingredient in Voltaren Gel and several oral NSAID products,” according to an FDA spokesperson.

Robert Shaw, MD, a rheumatologist at the Carroll County Arthritis and Osteoporosis Center in Westminster, Md., says physicians have long known to watch for liver damage in people who take diclofenac sodium pills, but that the new warnings make it clear that the gel also carries a risk.

“It’s especially a risk when patients come in and they’re on other medications that affect the liver or kidneys like statins. You’ve got to be aware that the gel can add to the side effect of these medicines,” he adds.

“As rheumatologists, we give methotrexate all the time. If you add the gel on top of that, even though there’s only a slight absorption, it is additive. That’s also true of the over-the-counter anti-inflammatories like Advil, Aleve and especially Tylenol,” Dr. Shaw says. “So I think the take-home message is – yes the gel has fewer side effects than diclofenac pills. But you still need to be ever vigilant to monitor for potential side effects, especially affecting the liver.”