其 他 安 全 警 示
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| European Union: European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs (English Only) |
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The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDS (non-steroidal anti-inflammatory drugs). At the outcome of the last review on the cardiovascular safety of non-selective NSAIDs, in 2006, the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the overall benefit-risk balance remained positive, but the possibility of a small increased risk of thrombotic events such as heart attacks or stroke with non-selective NSAIDs could not be excluded. This was particularly seen when NSAIDs were used at high doses and for long-term treatment.
Recently, results from the independent research project ‘safety of non-steroidal anti-inflammatory drugs’ (SOS) funded by the European Commission under the Seventh Framework Programme to evaluate the safety of NSAIDs, have become available. The CHMP will now review the results of this meta-analysis thoroughly, together with any other available clinical data (including data from clinical trials and epidemiological studies) and post-marketing safety reports on non-selective NSAIDs, to clarify whether there is any need to update the opinion issued in 2006.
Please refer to the following website in EMA for details :
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001369.jsp&mid=WC0b01ac058004d5c1
Situation in Hong Kong : In Hong Kong, NSAIDs-containing products are registered pharmaceutical products with ingredients such as diclofenac, ibuprofen, indomethacin, mefenamic acid and piroxicam. The similar issue has been released by MHRA and was posted on the website of Drug Office on 30 September 2011. A letter for healthcare professionals was issued on the same day. The issue will be discussed in the upcoming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, October 22, 2011
Issued at HKT 12:00
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