Celebrex Likely To Get Label Change Saying CV Risk Is Comparable To Ibuprofen, Naproxen
Despite concerns about difference in dosages and study discontinuation rates, US FDA advisory committee concludes that Pfizer's study demonstrated similar CV risk among the three NSAIDs.
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Heeding concerns of an advisory panel, US agency underscores that it is the lowest approved dose of the COX-2 inhibitor that has comparable CV risk to moderate doses of ibuprofen and naproxen.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Pfizer study finds Celebrex's CV risk comparable to naproxen and ibuprofen, but advisory committee wanted data on confounding factors and reasons for high dropout.