Diclofenac is the most popular of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) in 15 countries, according to studies, and it is listed as an essential medicine in 74 middle and high income countries, despite its association to heart attack and stroke in vulnerable patients, alerts a study published in PLoS Medicine manazine.
This risk, claim the authors, is almost as identical as the risk of Vioxx (rofecoxib) – a COX-2 inhibitor that was recalled worldwide in 2004 for cardiovascular risk. This has made experts request diclofenac be removed from the essential medicines lists (EMLs) and its marketing authorizations be revoked globally.
According to an October 2012 report of the Spanish Medicines Agency (Agencia Española del Medicamento) based on a thorough review of studies -meta analysis of clinical and observational studies, several observational studies recently published and the independent research project “Safety of non-steroidal anti-inflammatory drugs” (SOS)-, diclofenac seems to have higher cardiovascular risk compared to other NSAIDS, and similar risk to the observed for COX-2 inhibitors.
The document highlights that the information on the toxic effect of diclofenac and its association with cardiovascular events, though limited, seems to indicate cardiovascular risk increases with doses higher than 100 mg/day. But it adds: «it should be taken into account that even if cardiovascular risk profiles could be less favorable for diclofenac, when compared to naproxen or ibuprofen, the observed incremental risk is moderate».