The European Medicines Agency (EMA) is beginning a through analysis of the latest data on the cardiovascular risks from non-selective NSAIDS (non-steroidal anti-inflammatory drugs), that are primarily used as pain killers.
The case of Vioxx is well documented and lesser issues such as gastrointestinal irritation from Asprin are also well known. NSAIDS have been the subject of several European reviews in relation to safety and side effects. The most recent completed in 2006, by the Agency’s “Committee for Medicinal Products for Human Use” (CHMP) decided 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 ruled out. Side effects will always exist with any drug.
This was particularly apparent when NSAIDs were used at high doses and for long-term treatment. They concluded that future epidemiological studies would be needed to obtain new 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 7th framework program 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.
Written by Rupert Shepherd