COX-2s pending approval may also carry heart risksThe FDA has suggested that two COX-2 drugs pending approval, Merck's Arcoxia and Novartis' Prexige, carry similar cardiovascular risks to Merck's Vioxx which the drug maker pulled from the market last year after study results showed it carried heightened heart risks.
The FDA raised questions about the drugs in staff documents posted ahead of a meeting to take place later this month on COX-2s to examine their risks and benefits.
FDA documents released Friday discussing various studies involving Arcoxia and Prexige.
In the documents, the FDA said 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.
Novartis said in a briefing document that when all the clinical trial evidence for Prexige is reviewed "there is no evidence of an increased risk of cardiovascular events compared with placebo, naproxen, non-naproxen NSAIDs or all comparators."
A Merck spokesman told the Wall Street Journal the company continues, "to believe that Arcoxia has the potential to be a valuable, therapeutic alternative."
The FDA is holding a three-day meeting, beginning Feb. 16, with two outside panels of medical experts to discuss the risks and benefits of COX-2s and naproxen. At least one study has suggested naproxen may also increase the risks of heart attacks and strokes.