FDA Post-Marketing Clinical Trial Authority Should Be Bolstered, Topol Says
This article was originally published in The Pink Sheet Daily
Cleveland Clinic researcher Topol's suggestion is part of a JAMA editorial critical of COX-2s following Pfizer's announcement that Celebrex demonstrated an increased cardiovascular risk in a cancer trial. Topol advocates for second-line use and a contraindication in high-risk patients.
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The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.
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