The European Medicines Agency has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). Most of the data related to the three most widely used NSAIDs – diclofenac, ibuprofen and naproxen. Pharmacovigilance Risk Assessment Committee (PRAC) has called for the need for updated treatment advice for diclofenac in follow-on review. The formal review procedure for diclofenac will start at the next meeting of the PRAC, which will be held from 29-31 October 2012.

In relation to naproxen and ibuprofen, the Agency’s Committee for Medicinal Products for Human Use (CHMP) was of the opinion that the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines.

For diclofenac, the latest evidence appears to show a consistent but small increase in the risk of cardiovascular side effects compared with other NSAIDs, similar to the risks of COX-2 inhibitors, another class of painkillers. As a follow-on to this review, 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Pharmacovigilance Risk Assessment Committee (PRAC) will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice.

The CHMP concluded that evidence from newly available published data sources, including meta-analysis of clinical trials and observational studies, and the results of an EU-funded independent research project, the ‘Safety of non-steroidal anti-inflammatory drugs’ (SOS) project, on the cardiovascular safety of this class of medicines confirm findings from previous reviews, conducted in 2005 and 2006.

Moreover, CHMP had reviewed NSAIDs in relation to their 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.

The CHMP suggested that the European Commission fund independent epidemiological studies on the safety of NSAIDs through the 7th framework programme, in order to generate robust evidence for the Committee’s decision-making.

The SOS project was subsequently set up, 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 were the basis of the CHMP review and led to the conclusions.