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EMA reviews anti-inflammatory safety

The European Medicines Agency is to review the safety of non-selective non-steroidal anti-inflammatory drugs following new evidence into their association with cardiovascular events

The European Medicines Agency (EMA) is to review the safety of non-selective non-steroidal anti-inflammatory drugs following new evidence into their association with cardiovascular events.

The last review by the EMA took place in 2006, when the regulatory agency concluded the overall benefit-risk balance of the treatment remained positive, despite a small increased risk of events such as heart attacks or stroke.

Since then, several additional studies into the cardiovascular safety of NSAIDs have been published, including the independent meta-analysis 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.

The agency's Committee for Medicinal Products for Human Use (CHMP) will now review the results of this study, together with any other available clinical data post-marketing safety reports on non-selective NSAIDs, to clarify whether there is any need to update the opinion issued in 2006.

Non-selective NSAIDS are used in the relief of pain and inflammation in a wide range of conditions, including arthritic, acute musculo-skeletal disorders and other painful conditions resulting from trauma.

Treatments being reviewed include diclofenac, etodolac, ibuprofen, indomethacin, ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam.

24th October 2011

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