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Celebrex CV Risk v. Naproxen, Ibuprofen: US FDA Does Not Recommend Differential Labeling

 
• By Brenda Sandburg

Advisory committee to evaluate whether PRECISION trial shows celecoxib cardiovascular safety is comparable to naproxen and ibuprofen and if naproxen and ibuprofen use should be contraindicated with aspirin.

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A US FDA advisory panel will delve into the data of the PRECISION trial, which evaluated the cardiovascular risk of Pfizer Inc.'s Celebrex (celecoxib) compared to naproxen and ibuprofen, to determine if the study supports the cardiovascular safety of Celebrex. But the change that could come out of the meeting is a revision to the nonprescription labeling for naproxen and ibuprofen.

FDA has asked the panel to vote only on whether the over-the-counter labeling for these products should be changed to...

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