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Published on 21 October 2011

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EMA reviews CVR safety of non-selective NSAIDs

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The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDS).

NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions.

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.

Further epidemiological studies were needed to obtain additional data on pertinent safety aspects of NSAIDs and therefore the Agency recommended in 2006 that the European Commission fund an independent epidemiological study to further explore the risk of gastrointestinal and cardiovascular toxicity of these medicines.

Since 2006, a number of new studies on the cardiovascular safety of NSAIDs have been published.

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.

European Medicines Agency

 



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