Painkiller May Raise Heart Attack Risk

Diclofenac in high doses may cause heart issues warns European Medicines Agency

(RxWiki News) Millions take diclofenac to relieve the pain of arthritis and other ailments. The European Medicines Agency, however, has issued a warning that this medication may raise heart attack risk.

The European Medicines Agency (EMA)—which is the equivalent of the US Food and Drug Administration — warns against taking high doses of diclofenac.

The EMA advised patients who have serious underlying heart or circulatory conditions to not over use this medication. This warning focused on heart failure, heart disease, circulatory problems, a previous heart attack or stroke.

The EMA stresses that the benefits of diclofenac still outweigh the risks. 

"Consult a doctor before taking diclofenac."

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) announced its decision after a large international study published last month in The Lancet found that long-term use of painkillers such as diclofenac and ibuprofen in high doses elevates the risk of a heart attack, stroke or dying from cardiovascular disease by about one-third. High doses were defined as 150 mg daily for diclofenac and 2400 mg daily for ibuprofen.

PRAC also recommended that patients with certain cardiovascular risk factors (such as high blood pressure, raised blood cholesterol, diabetes or smoking) should only use diclofenac after careful consideration.

Healthcare professionals are advised to periodically reassess the need for patients to continue taking the medicine.

In the US, diclofenac is sold under the brand names Cambia, Cataflam, Voltaren, Voltaren-XR and Zipsor. The medication is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs works by stopping the body's production of a substance that causes pain, fever, and inflammation. NSAIDs include ibuprofen and naproxen.

In addition to easing pain, tenderness, swelling and stiffness of arthritis and back ache, diclofenac is also used to treat painful menstrual periods and pain from other causes.

The effects of diclofenac on the heart and circulation is similar to those of selective COX-2 inhibitors or coxibs, another group of NSAID painkillers, according to PRAC. Common COX-2 inhibitors are celecoxib (Celebrex) and valdecoxib (Bextra). In 2009, the arthritis drug Vioxx was recalled because of a study finding that it increased risk of heart attack and stroke.

Reviews of NSAIDs in 2005, 2006 and 2012 have confirmed that NSAIDs as a class of medication are associated with a small increased risk of arterial thromboembolic (blocking of a blood vessel by a clot) events.  These events can lead to heart attack or stroke, particularly if the NSAIDs are used at high dose and for long-term treatment.

The product information for all NSAIDs warns of this risk, and recommends that NSAIDs be used at the lowest effective dose for the shortest period of time necessary to control symptoms.

Registered pharmacist Jason Poquette, BPharm, RPh, told dailyRx News, “I would remind my patients that this does not necessarily indicate any additional risk for patients using this NSAID at normal dosages and for limited durations.”

He added, “The study did not appear to exclude the possibility that high-dose diclofenac users may have already been at higher risk for heart attack or stroke. We know, for example, that arthritis [a disease which might cause patients to take higher dosages of diclofenac] is correlated with a greater risk for heart disease."

"Therefore, just as the agency reporting the study, I would advise my patients that the reported risks still do not exceed the potential benefit of using diclofenac in recommended dosages as prescribed by a doctor.”

Poquette recommended that patients who are especially concerned or who may be at risk for heart disease already talk with their doctor about other NSAID options, “...although there is no guarantee such options will actually lower their risk for cardiovascular events.”

The European Medicines Agency issued this warning on diclofenac on June 14.

Review Date: 
June 14, 2013