New Celebrex Trial Will be Conducted
Wednesday, February 23rd, 2005FDA advisers unanimously voted that Celebrex increases the risk of heart attack and stroke. The advisers recommended the arthritis medicine carry the FDA’s most severe warning, known as a black box.
In response to the FDA panel meeting, Pfizer Inc. said it will no longer attempt to prove its drug has a heart benefit and will instead compare the most commonly used dose of Celebrex to another anti-inflammatory pill to prove there is no greater risk for the heart than similar drugs.
The trial, according to Jeffrey Borer, chief of the division of cardiopathophysiology at Weill Cornell Medical College and one of the researchers designing the study, would be considerably bigger and involve at least 20,000 patients. Investigators for the trial weighed naproxen as a likely comparator, Borer said on a conference call, but no final decision has been made yet. Ibuprofen may also be considered.
Though it could take years before any trial shows Celebrex is safe, for Pfizer, the wait could be well worth it.
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