Piroxicam (Feldene) is under close scrutiny at the European Medicines Agency (EMEA), as the cardiovascular safety of all non-selective non-steroidal anti-inflammatory drugs (NSAIDs) is reviewed for the second time in 12 months.
Referring to new data and analyses on the cardiovascular safety of NSAIDs from clinical and epidemiological studies, the EMEA said its Committee for Medicinal Products for Human Use (CHMP) had been asked to review the cardiovascular safety of NSAIDs in the context of their overall benefit-risk profile.
The new data signalled “a potential increased thrombotic risk” – such as a heart attack or stroke – for some of these NSAIDs, the EMEA said, especially when they were used in long-term treatment.
The EMEA noted that when the CHMP had reviewed the products last year, the committee had undertaken to maintain non-selective NSAIDs under surveillance. It had also recommended last October a number of changes in the way healthcare professionals prescribed the products to ensure consistency across Europe.
Three non-selective NSAIDs – ketoprofen, ketorolac and piroxicam – have been further examined by the CHMP since last October. The committee urged a “more cautious” use of all three compounds, but was concerned that piroxicam “may have a less favourable gastrointestinal safety profile and higher risk of skin reactions” compared with other non-selective NSAIDs.
“At the request of the European Commission, the CHMP has now started a formal review of the overall benefit-risk profile of piroxicam,” the EMEA said, adding that the benefits associated with the approved use of ketoprofen and ketorolac continued to outweigh their associated risks.
The CHMP had already started reviewing available safety data on non-selective NSAIDs from clinical and epidemiology studies, the EMEA said, and would be in a position to give a scientific opinion on the cardiovascular safety of the products during its next meeting on 16-19 October. It would also be making recommendations on how to address any safety concerns that might be identified.
Source:OTC Bulletin
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