EMEA CONCLUDES REVIEW OF NON-SELECTIVE NSAIDS

The European Medicines Agency (EMEA) has concluded its review of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and found that the benefit-risk balance for is favorable. This latest review, announced in September, was based on newly available data and analyses on cardiovascular safety stemming from clinical and epidemiological studies that signal a potentially increased thrombotic risk (such as heart attack or stroke) for non-selective NSAIDs, especially when used at high doses and in long-term treatment.

The agency's Committee for Medicinal Products for Human Use (CHMP) concluded that:

• Non-selective NSAIDs are important treatments for arthritis and other painful conditions;
• It cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment; and
• The overall benefit-risk balance for non-selective NSAIDs remains favorable when used in accordance with the product information, namely on the basis of the overall safety profile of the respective non-selective NSAID, and taking into account the patient's individual risk factors.

Previous reviews of the safety of non-selective NSAIDs and COX-2 inhibitors were also taken into account. The CHMP confirmed its previous advice for doctors and patients to continue to use the lowest effective dose for the shortest possible duration to control symptoms.

To view the CHMP opinion, go to www.emea.eu.int/pdfs/human/opiniongen/nsaids.pdf.