Cardiovascular risk with non-steroidal anti-inflammatory drugs: clinical implications

In February 2014, the US Food and Drug Administration (FDA) convened an advisory committee meeting to discuss the accumulated data relating to the cardiovascular risk of non-steroidal anti-inflammatory drugs (NSAIDs) and the potential implications on the class prescription labeling. The committee recommended, though not unanimously, that (1) the current data does not support the conclusion that naproxen has a lower risk of thrombotic events than other NSAIDs; (2) there is no latency period for the risk of cardiovascular thrombotic events; (3) there are some patient populations at increased risk for events; and (4) equipoise remains in the major ongoing trial designed to address these issues further. The clinical implications of the FDA deliberations as well as the recently published meta-analyses and observational studies are discussed. With the information available today, there is insufficient evidence to conclude that there are significant differences between the approved NSAIDs with regard to the potential for cardiovascular events. An approach for balancing the major risks associated with NSAIDs is suggested. Clinicians should continue to use the current FDA NSAID labeling language to guide their decision making for individual patients until such time as the FDA makes changes.