Celebrex Should Stay On Market, FDA Panel Says, But Splits On Vioxx, Bextra
Pfizer's COX-2 inhibitor Celebrex can remain on the market with new labeling warnings, including a "black box" about the increased risk of cardiovascular events, an FDA advisory committee recommended Feb. 18
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With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.
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.
Companies with pipeline pain products may see a smoother path through FDA, but Celebrex already has generic competition in the US, limiting the benefits even if it could get the black box removed from labeling and Pfizer also recently settled a lawsuit for $468 million related to the drug's safety.