New safety advice for diclofenac – CMDh endorses PRAC recommendation

01-Jul-2013 - United Kingdom

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), has endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect). The new advice aims to minimise the risks of effects on the heart and circulation from these medicines.

This follows a recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) which found that the effects of systemic diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers. This applies particularly when diclofenac is used at a high dose and for long-term treatment. The PRAC therefore recommended that the same precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should be applied to diclofenac.

The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied.

The CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU.

Diclofenac is a widely used medicine for relieving pain and inflammation, particularly in painful conditions such as arthritis. It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs). The safety of NSAIDs has been closely monitored by regulatory authorities in the EU. Reviews of these medicines carried out in 2005, 2006 and 2012 have confirmed that NSAIDs as a class are associated with a small increased risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, which in some cases has led to heart attack or stroke, particularly if used at high dose and for long periods.

A class warning of this risk is in place and the product information for all NSAIDs recommends that these medicines be used at the lowest effective dose for the shortest period of time necessary to control symptoms. As the risk is known to be somewhat higher with the subgroup of NSAIDs known as selective COX-2 inhibitors, increased measures to minimise risk are recommended in their product information.

The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs. The latter identified a small increased risk of these cardiovascular side effects with diclofenac compared with other NSAIDs - an increase similar to that seen with the COX-2 inhibitors. The cardiovascular risk with any NSAID depends on a person’s underlying risk factors, such as high blood pressure and cholesterol levels and also any underlying heart or circulatory conditions. About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year. The overall number of heart attacks in people at moderate risk would be expected to increase by around 3 cases per year for every 1,000 people treated with diclofenac (to 11 per 1,000 people per year).

https://www.bionity.com/en/news/143795/new-safety-advice-for-diclofenac-cmdh-endorses-prac-recommendation.html