The Ansm has just restricted the indications for Voltarene, an anti-inflammatory widely prescribed to relieve pain. The goal, to minimize the cardiovacular risk.
Voltarene, an anti-inflammatory widely prescribed to relieve pain and inflammation, is talked about again! Indeed, in April 2013, the French Society of Rheumatology (SFR) already wished to draw attention to recent international studies showing a (moderate) increase in the risk of cardiovascular accident with this non-inflammatory anti-inflammatory drug. steroid (NSAID). But this Wednesday, it is the Medicines Safety Agency (Ansm) which indicates to health professionals the new restrictions on the use of diclofenac-based medicines, the originator of which is Voltarene.
The evaluation of the cardiovascular risk profile of diclofenac, which was carried out at the end of 2012 and at the beginning of 2013 within the European Medicines Agency (EMA), has admittedly just been completed.
On the one hand, the study confirmed the risk of cardiovascular adverse effects (such as myocardial infarction or stroke) for all non-selective NSAIDs. On the other hand, it demonstrated a higher cardiovascular risk with diclofenac than with other classic NSAIDs.
Even if the authors concluded that the benefit / risk ratio of the drug remained favorable, new contraindications have just been introduced in the summary of product characteristics (SPC), in order to minimize this cardiovascular risk.
Among these usage restrictions, the Agency indicates that diclofenac is now contraindicated in patients with:
– proven congestive heart failure;
– ischemic heart disease;
-peripheral arterial disease and / or cerebrovascular disease.
Finally, for patients treated with diclofenac and suffering from cardiovascular disease, their treatment should be reassessed by their doctor, underlines the Ansm. In addition, treatment with diclofenac should be initiated only after an assessment of the benefit / risk ratio in patients with cardiovascular risk factors (arterial hypertension, hyperlipidemia, diabetes mellitus and smoking). Also, the lowest possible effective dose of diclofenac for the shortest time to ensure symptom control should be used.
Not enough to reassure patients, because according to a Ansm ranking, diclofenac was the 14th best-selling active substance in France for 2011.
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