EMEA TO REVIEW SAFETY OF NON-SELECTIVE NSAIDS

A year after its last review, the European Medicines Agency (EMEA) has announced it will look again at the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs).

Last October the agency's Committee for Medicinal Products for Human Use (CHMP) recommended a number of changes in the way healthcare professionals prescribe non-selective NSAIDs to ensure consistency across the European Union (EU). New data and analyses are now available on the cardiovascular safety of non-selective NSAIDs stemming from clinical and epidemiological studies that signal a potential increased thrombotic risk (such as heart attack or stroke) for some of these NSAIDs, especially when used in long-term treatment. The CHMP has been asked to review the cardiovascular safety of NSAIDs in the context of their overall benefit-risk profile and will give a scientific opinion on the cardiovascular safety of non-selective NSAIDs during its next meeting in October.

Since the last review, three non-selective NSAIDs have been further examined: ketoprofen, ketorolac and piroxicam. While the recommendations are for a more cautious use for all three of these compounds, the committee was concerned that piroxicam may have a less favorable gastrointestinal safety profile and higher risk of skin reactions compared with other non-selective NSAIDs. At the request of the European Commission, the committee has now started a formal review of the overall benefit-risk profile of piroxicam. With respect to ketoprofen and ketorolac, the CHMP has concluded that their benefits continue to outweigh the risks associated with their approved use. The committee will also look at diclofenac, etodolac, ibuprofen, indomethacin, meloxicam, nabumetone, naproxen and nimesulide.