Liver Toxicity With Topical Diclofenac Sodium (VOLTAREN)

The Food and Drug Administra­tion (FDA) is now requiring pharmaceutical companies to warn patients about the possibility of liver toxicity when using products con­taining the arthritis drug diclofenac sodium (VOLTAREN) that are applied directly to the skin.

According to a letter sent by the FDA to health care professionals on Dec. 4, 2009, professional product labels (sometimes called package inserts) for all topical products con­taining diclofenac sodium must have the liver toxicity warnings. The Table lists the four diclofenac-containing topical prod­ucts currently available in the U.S.

Liver reactions with diclofenac

It is commonly believed that drugs applied on the skin act only in a pre­cise local area and are safer than the same drugs taken orally. However, this view is mistaken.

In the case of topical diclofenac, the total amount of the drug ab­sorbed into the blood is lower than the amount absorbed from oral diclofenac products. But enough diclofenac is absorbed through the skin to cause the same side effects as the oral drugs. These side effects include heart problems, gastrointes­tinal bleeding and liver toxicity.

Diclofenac is a member of the nonsteroidal anti-inflammatory drugs (NSAID) class of drugs that includes a number of very popular products such as ibuprofen (MOTRIN), celecoxib (CELEBR­EX) and naproxen (NAPROSYN). These drugs have been associated with reports of severe liver reactions, including liver cell death, jaundice (yellowing of the skin or eyes), liver inflammation with and without jaundice, and liver failure. Some of these cases have resulted in liver transplants, and some have resulted in death.

Up to 15 percent of patients tak­ing NSAIDs may experience border­line elevations of one or more liver tests used to check for possible liver toxicity.

The following is a list of liver toxicity warning signs. Patients who experience any of these symptoms should stop taking the offending drug immediately and contact their health care provider as soon as possible.

• fatigue
• loss of appetite
• nausea
• yellowing of the skin and/or eyes
• right upper belly pain
• light-colored stools
• dark urine
• itchy skin
• lethargy
• diarrhea
• flu-like symptoms

What You Can Do

Be aware that topical NSAIDs can cause the same side effects as their oral counterparts.

Some doctors believe people over age 70 should be started with half the usual dose of NSAIDs because these age groups are more likely to have reduced liver and kidney func­tion. In general, patients over 60 — and especially those with decreased kidney function — should take less than the usual adult dose.

NSAIDs, including diclofenac sodium, must be dispensed with an FDA-approved Medication Guide written specifically for consumers in nontechnical language. Medication Guides are only dispensed for drugs that the FDA has determined pres­ent serious public health concerns.

Read the NSAID Medication Guide when you refill any prescrip­tion for an NSAID, as the informa­tion may have been updated. The Medication Guides for diclofenac and other NSAIDs can be obtained from any local pharmacist, or online from the FDA at: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Topical Diclofenac Products

* Diclofenac epolamine, sold as FLECTOR PATCH, also requires the same warnings as diclofenac sodium and the other NSAIDs.