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Liver Toxicity With Topical Diclofenac Sodium (VOLTAREN)

Worst Pills, Best Pills Newsletter article March, 2010

 

Black Box Warning: Cardiovascular and Gastrointestinal Risk

Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, any of which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk fac­tors for cardiovascular disease may be at greater risk.

Voltaren Gel is...

 

Black Box Warning: Cardiovascular and Gastrointestinal Risk

Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, any of which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk fac­tors for cardiovascular disease may be at greater risk.

Voltaren Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk
NSAIDs cause an increased risk of seri­ous gastrointestinal adverse events includ­ing bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

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.

 

Beware of Pharmacy-Com­pounded Topical NSAIDs

Some pharmacies engage in a prac­tice known as pharmacy compound­ing, in which pharmacists mix drugs to create customized medications as a speciality and produce varying (although sometimes substantial) quantities of their own drugs start­ing from scratch.

Among other things, topical diclofenac products both alone and mixed with other drugs are produced and promoted by these pharmacies.

Pharmacy-compounded prod­ucts are not FDA-approved for any purpose and are produced in facilities that are not regulated under the agency’s Good Manufacturing Practice guidelines.

Patients purchasing products from compounding pharmacies may not be told that these products are not FDA-approved or receive the warn­ing information that is required to be distributed with FDA-approved and FDA-regulated NSAID products.

Topical Diclofenac Products

 

Generic Name

BRAND NAME

FDA-Approved Use

diclofenac epolamine

FLECTOR PATCH*

pain due to minor strains, sprains and contusions

diclofenac sodium

PENNSAID TOPICAL SOLUTION

osteoarthritis of the knee(s)

diclofenac sodium

SOLARAZE TOPICAL GEL

topical treatment of actinic keratoses (precancer­ous skin changes due to sun damage)

diclofenac sodium

VOLTAREN GEL

osteoarthritis of joints such as the knees and those of the hands

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