EMA Reviews Cardiovascular Risks of Non-selective NSAIDs

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

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

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 pertinen