Review ordered of studies using Celebrex, Bextra

The U.S. Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.‘s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.

The FDA also said doctors and consumers should weigh individual benefits and risks when taking painkillers, saying patients vulnerable to gastric bleeding may be appropriate candidates for Cox-2 drugs such as Celebrex and Bextra.

“The actions that we’re recommending in the advisory are for more limited prescribing than would currently be included in the approved labeling for these products,” John Jenkins, director of the FDA’s Office of New Drugs, told reporters on a conference call

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Revision date: June 20, 2011
Last revised: by Sebastian Scheller, MD, ScD