Safety advice on particular drugs or classes of drugs
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| Updates on the use of diclofenac |
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1. The United Kingdom: MHRA confirms advice on the use of diclofenac
The MHRA confirmed that patients with serious underlying heart conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke should no longer use diclofenac, This follows completion of a European review which found a small increased risk of heart attack and stroke.Dr. Sarah Branch, Deputy Director of the MHRA’s Vigilance and Risk Management of Medicines Division said: “Whilst this is a known risk and warnings have been included in patient and healthcare information for some time, this advice is now being updated.For many patients diclofenac will continue to provide safe and effective pain relief but is no longer suitable for certain at risk groups. Those with underlying heart conditions currently taking diclofenac should speak to their GP or pharmacist at their next routine visit to consider an alternative pain relief treatment. Patients with certain cardiovascular risk factors such as high blood pressure, raised cholesterol, diabetes and smoking should only use diclofenac after careful consideration with their GP or pharmacist.”
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON287042
2. European Union: New safety advice for diclofenac –Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorses Pharmacovigilance Risk Assessment Committee (PRAC) recommendation
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 (EMA)'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.
Detailed recommendations for patients and healthcare professional are available at the link below.
http://www.ema.europa.eu/../news_detail_001830.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 250 registered pharmaceutical products containing diclofenac of which 163 are indicated for systemic use (given by means such as capsules, tablets or injections) and are prescription-only medicines. Related news has been released by MHRA and EMA and was posted on the Drug Office website on 30 September 2011, 22 October 2011, 20 October 2012, 31 May 2013 and 29 June 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to NSAIDs was issued on 30 September 2011. The matter was discussed by the Registration Committee of the Pharmacy Poisons Board in the meeting in February 2013 and the Committee has concluded that NSAIDs-containing products other than external preparations should include new safety warnings regarding the cardiovascular risk.
Ends/ Saturday, June 29, 2013
Issued at HKT 17:00
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