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news.The FDA has revealed that its upcoming COX-2 cardiovascular safety review will include two products not yet approved in the US, namely Novartis' Prexige and Merck & Co.'s Arcoxia.
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Reports so far suggest that the FDA believes the cardiovascular risks that resulted in Merck’s voluntary withdrawal of Vioxx (rofecoxib) are a class effect.
As well as looking at Vioxx and FDA-approved drugs Celebrex and Bextra (both marketed by Pfizer), the review is expected to include data for Arcoxia (etoricoxib) and Prexige (lumiracoxib), concluding that each has a potential cardiovascular risk. Parecoxib (Pfizer’s Dynastat) is also to be included in the briefing materials, as the FDA issued it a ‘not approvable’ decision in 2000.
According to reports, Novartis’ Prexige has demonstrated cardiovascular risks similar to that of Vioxx in a recent trial comparing Prexige to naproxen. However, a second study showed Prexige to have no increased risk compared to ibuprofen.
Merck’s Arcoxia has also reportedly fared worse than other treatments in recent trials in terms of cardiovascular safety.