EU warns of CV safety risk with diclofenac

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The European Medicines Agency has issued its final review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs), concluding that there is a “small increase in the risk of cardiovascular side effects” with diclofenac, compared with other NSAIDs.

The agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that evidence from newly available published data sources, including a meta-analysis of clinical trials and observational studies, and the results of an Europena Union-funded independent research project, the Safety Of non-Steroidal anti-inflammatory drugs (SOS) project, on the cardiovascular safety of this class of medicines confirmed findings from previous reviews, conducted in 2005 and 2006.

Most of the data were related to the three most widely used NSAIDs—diclofenac, ibuprofen and naproxen. In relation to naproxen and ibuprofen, the CHMP determined that the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines.

The small increase in the risk of cardiovascular side effects for diclofenac compared with other NSAIDs is similar to the risks of COX-2 inhibitors, another class of painkillers, according to the agency. As a follow-up to this review, the agency’s new Pharmacovigilance Risk Assessment Committee will assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice.

The CHMP had reviewed NSAIDs for possible cardiovascular risks, gastrointestinal side effects and serious skin reactions in 2005 and in 2006. At the time the CHMP concluded that the overall benefit-risk balance of these medicines remained positive, but that a small increased cardiovascular risk could not be excluded. The committee also acknowledged that the available data were limited and that methodological limitations of previous studies and existing knowledge gaps made it difficult to reach firm conclusions. 

Previously, CHMP suggested that the European Commission fund independent epidemiological studies on the safety of NSAIDs through the seventh framework program to generate evidence for the committee’s decision-making. The SOS project was subsequently established to assess and compare the risk of cardiovascular and gastrointestinal events of NSAIDs. The accumulating findings from published studies together with the results of the SOS were the basis of the CHMP review and led to the conclusions described above.

The formal review procedure for diclofenac will occur on Oct. 29-31.

The report is on the agency's website.