Safety advice on particular drugs or classes of drugs
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| The United Kingdom: MHRA response to published research paper concerning non-steroidal anti-inflammatory drugs (NSAIDs) and the cardiovascular risks |
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The MHRA have made the following statement in response to the research paper published in the Lancet concerning non-steroidal anti-inflammatory drugs (NSAIDs) such as Ibuprofen and Diclofenac and the risks of cardiovascular problems. Dr Sarah Branch, the MHRA’s Deputy Director for the Vigilance and Risk Management and of Medicines, said: "These findings in the Lancet are not new and confirm the conclusions reached in October 2012 by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac are effective painkillers. A small increase in cardiovascular risk is associated with long-term use of ibuprofen and diclofenac at high doses. The short term use of ibuprofen at doses available without a prescription has not been associated with an increased risk. The MHRA's current treatment advice for all NSAIDs is for people to use the lowest effective dose, for the shortest duration necessary to control symptoms. If people have any questions about their treatment they should contact their pharmacist or doctor."
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Whatsnew/CON282755
In Hong Kong, NSAIDs-containing products are registered pharmaceutical products with ingredients such as diclofenac, ibuprofen, naproxen, indomethacin, mefenamic acid and piroxicam. Related news has been released by MHRA and EMA and was posted on the Drug Office website on 30 September 2011, 22 October 2011 and 20 October 2012. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug 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 concluded that NSAIDs-containing products other than external preparations should include new safety warnings regarding the cardiovascular risk.
Ends/ Friday, May 31, 2013
Issued at HKT 15:30
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