Small Increased Risk of CV Events With Diclofenac


October 19, 2012

LONDON — The European Medicines Agency (EMA) has finalized a review of recently published information on the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) and concludes that the latest evidence shows a consistent but small increase in the risk of cardiovascular side effects with diclofenac compared with other NSAIDs [1]. The risk with diclofenac is "similar to the risks of COX-2 inhibitors," it states.

As a follow-on, the agency's new Pharmacovigilance Risk Assessment Committee (PRAC) will now assess all available data on diclofenac--both published and unpublished--"to consider the need for updated treatment advice," starting at its next meeting, which will be held October 29–31, 2012.

In this latest review into the safety of NSAIDs, the EMA's Committee for Medicinal Products for Human Use (CHMP) also considered evidence on the cardiovascular safety of other NSAIDs, primarily ibuprofen and naproxen. In relation to these two agents, the CHMP was of the opinion that "the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines."

The CHMP had reviewed NSAIDs in relation to their possible cardiovascular risks in 2005 and 2006 and at the time concluded that the overall benefit/risk balance of these medicines remained positive but that a small increased cardiovascular risk could not be excluded.

It also acknowledged, however, that the available data were limited and that "methodological limitations of previous studies and existing knowledge gaps made it difficult to reach firm conclusions." As a result, it suggested that the European Commission fund independent epidemiological studies on the safety of NSAIDs, in order to generate robust evidence for the committee’s decision-making.

The Safety of Nonsteroidal Anti-inflammatory Drugs(SOS) project was subsequently set up at Erasmus University in the Netherlands, aimed at assessing and comparing the risk of cardiovascular and gastrointestinal events of NSAIDs. The accumulating findings from published studies, together with the results of the SOS project, were the basis of the CHMP review and led to today's conclusions.