The Special Case of Diclofenac Enliven Archive | www.enlivenarchive.org 1 2014 | Volume 1 | Issue 1 * Corresponding author: Dr Gwenaëlle VEYRAC, Clinical Pharmacology Department, CHU of Nantes, Institute of Biology, 9 quai Moncousu, F-44093 NANTES Cedex, France, Tel: +33240084096; Fax : +33240084097; E-mail: gwenaelle.veyrac@chu-nantes.fr Citation: Darnis D,Veyrac G,Jolliet P (2014) The Special Case of Diclofenac. Enliven: Pharmacovigil Drug Saf 1(1):003. Copyright:@ 2014 Gwenaëlle VEYRAC.This is an Open Access article published and distributed under the terms of the Creative Commons Attribution License, that permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. Introduction Summer 2013 brought new recommendations on the use of diclofenac. Diclofenac is a Non Steroidal Anti-Inflammatory Drug indicated for treating painful chronic pathologies and/or painful acute pathologies [1]. This recent piece of information comes directly from the European Medicines Agency, who, in 2011, had started surveying how safe the molecule was. Since rofecoxib, a selective inhibitor of COX-2, was withdrawn from the market in 2005, the potential cardio-vascular risks of NSAIDs were examined. Indeed, the APPROVE study had shown that the use of this anti-inflammatory drug increased risks of cardiovascular accidents [2]. An independent research project on « the safety of NSAIDs » was then implemented. Since 2006, the results of the project, along with a number of other studies, put forward more proofs on the links between non selective NSAIDs and strokes and myocardial infarctions. Collected data also indicated a higher risk of thrombotic events with diclofenac than with the other non selective NSAIDs [3]. This increase was similar to that observed with COX-2 inhibitors. Therefore, the Pharmacovigilance Risk Assessment Committee started in November 2012 a new study on diclofenac, which led to the aforementioned recommendations. Methods and Materials Diclofenac belongs to the Non Steroidal Anti-Inflammatory drug class. With their analgesic, anti-inflammatory, antipyretic and anti-thrombotic properties, NSAIDs are among the most widely used therapeutic agents. They are indicated for a wide range of ailments, such as osteoarthritis, arthritis, headaches, back pains and dysmenorrhea [1]. That is why more than 30 million people throughout the world use it daily [4]. A growing and aging population combined with free access to drugs and larger indications are the causes for the constant increase of the use of these molecules. There are various families of molecules among the NSAIDs, based on their chemical structures (Table 1). Diclofenac belongs to family of carboxylic acid derivatives. Received Date: 9 th September 2014 Accepted Date: 13 th October 2014 Published Date: 16 th October 2014 Rapid Communication Enliven: Pharmacovigilance and Drug Safety Domitille Darnis 1 , Gwenaëlle Veyrac 1 , and Pascale Jolliet 1 1 Centre Régional de Pharmacovigilance de Nantes, CHU de Nantes Abstract 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. Keywords Non Steroidal Anti-Inflammatory Drugs; Diclofenac; Cardiovascular risk Abbreviations NSAID: Non Steroidal Anti-Inflammatory Drug; COX-1: Cyclooxygenase-1; COX-2: Cyclooxygenase-2 www.enlivenarchive.org