The European Medicines Agency has decided to revisit the cardiovascular safety of prescription non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in the light of new data.

Just under a year ago, the EMEA’s regulatory advisory body, the Committee for

Medicinal Products for Human Use (CHMP) concluded that there was no need to strengthen the warning labels on non-selective NSAIDs such as ibuprofen, naproxen and diclofenac, on the available data.

However, the CHMP advised a number of changes in the way healthcare professionals prescribe the drugs to ensure consistency across the European Union.

The probe was prompted by the withdrawal of Merck & Co’s COX-2-selective NSAID Vioxx (rofecoxib) in September 2004, after it was found to increase the risk of thrombotic diseases such as heart attack and stroke. The resulting investigation into the Vioxx data also raised questions about the safety of other less selective NSAIDs.

One year on, new data and analyses are now available on the cardiovascular safety of non-selective NSAIDs stemming from clinical and epidemiological studies, which signal a potential increased risk of heart attack or stroke for some of these drugs, especially when used in long-term treatment.

In June, for example, a meta-analysis published in the British Medical Journal suggested that when ibuprofen and diclofenac were given at high doses the risk of heart attack was elevated, although the reverse seemed to be the case with high-dose naproxen.

“The CHMP has now been asked to review the cardiovascular safety of NSAIDs in the context of their overall benefit-risk profile,” said the agency in a statement. It will deliver a scientific opinion on the cardiovascular safety of non-selective NSAIDs during its next meeting on October 16-19, including recommendations on how to address any safety concerns that may be identified.

The EMEA added that since the 2005 review, three other non-selective NSAIDs - ketoprofen, ketorolac and piroxicam - have come under scrutiny.

The recommendations are for a more cautious use for all three of these compounds, the CHMP is concerned that piroxicam may have a less favourable gastrointestinal safety profile and higher risk of skin reactions compared to other non-selective NSAIDs. It 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,” said the regulator.