Avrupa İlaç Ajansı (EMA) Farmakovijilans Risk Değerlendirme Komitesi (PRAC), diclofenac hakkındaki görüşünü tamamladı (İng)



EMA Committee Concludes Diclofenac Poses Similar Risks as COX-2 Inhibitors

Michael O’Riordan – Jun 2013

LONDON, UK — The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has completed its review of diclofenac and concluded that the drug poses similar risks as selective COX-2 inhibitors, particularly when used in high doses (150 mg) or when used long term [1].

Still, committee says the benefits of diclofenac exceed the risks and that physicians should take the same precautions to minimize thromboembolic events as they do with patients treated with selective COX-2 inhibitors.

“Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems, or a previous heart attack or stroke, should not use diclofenac,” according to PRAC. “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 will also be advised to periodically reassess the need for patients to continue taking the medicine.”

The review conducted by PRAC was launched in October 2012 after the EMA completed a report on published information assessing the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs). Like PRAC, the EMA concluded that there was a consistent but small increase in the risk of cardiovascular side effects withdiclofenaccompared with other NSAIDs and that this risk was on par with that observed with COX-2 inhibitors.

The current PRAC conclusions are based on all published and unpublished data. Its recommendations will now be forwarded to the Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh), a regulatory body representing member European Union states, which will adopt a final position.


  1. European Medicines Agency. PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors [press release]. June 14, 2013. Available here,


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