The FDA suggested two COX-2 drugs pending approval, Merck’s Arcoxia and Novartis’ Prexige, carry similar cardiovascular risks to Merck’s Vioxx.
The FDA raised questions about the drugs in staff documents posted ahead of this week’s joint-session on COX-2s to examine their risks and benefits.
The FDA said in the documents that there was an increase in the number of cardiovascular events and hypertension in people using Arcoxia.
The documents also said a study involving patients taking Prexige and patients taking naproxen showed there was an increase in the number of cardiac deaths and non-fatal heart attacks and strokes among those taking Prexige.