Enliven: Pharmacovigilance and Drug Safety

The Special Case of Diclofenac
Author(s): Domitille Darnis, Gwenaelle Veyrac, and Pascale Jolliet

Since rofecoxib was withdrawn from the market in 2005, the controversy keeps going on about the cardiovascular risk of Non Steroidal Anti-Inflammatory Drugs (NSAIDs). With their analgesic, anti-inflammatory, antipyretic and anti-thrombotic properties, NSAIDs are among the most widely used therapeutic agents. They are also known for their side effects: dyspepsia, peptic ulcerations, fluid retention, high blood pressure ... The recent revelation of thrombotic events due to the use of coxibs (selective COX-2 inhibitors) has led to a thorough study of this risk with every NSAID. The results have shown that the vascular risks of diclofenac were comparable to coxibs. In 2013, new recommandations have been announced to warn patients and healthcare professionals about the safe use of diclofenac. Beyond these European recommendations, the use of diclofenac should be revised on a worldwide scale since its use is very common in countries such as China and India.