European Agency Reviews CV Safety of NSAIDs: Notes Possible Updated Treatment Recommendations for Diclofenac Needed

The European Medicines Agency has finalized a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs) and has found that the latest evidence for diclofenac appears to show a consistent but small increase in the risk of cardiovascular side effects , according to a statement released Oct. 19 from the Agency.


According to the statement, the small increase in the risk of cardiovascular side effects for diclofenac "are similar to the risks of COX-2 inhibitors, another class of painkillers." In addition, the Agency found the current treatments recommendations for naproxen and ibuprofen "adequately reflects the knowledge regarding the safety and efficacy of these medicines."

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Risk Assessment Committee (PRAC) will now "assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice."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 formal review for diclofenac will start on Oct. 29. Stay tuned to for updates.

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