NSAID Safety Review: FDA Panel Seeks Continued PRECISION From Pfizer

Pfizer’s long-term safety outcome study comparing Celebrex, ibuprofen and naproxen has its flaws, but FDA advisory committee says its data will be far superior to meta-analyses or observational studies.

Pfizer Inc.’s outcomes trial comparing its non-steroidal anti-inflammatory drug Celebrex (celecoxib) to ibuprofen and naproxen may not be perfect, but it may be FDA’s best shot at truly understanding whether the three NSAIDs come with different cardiovascular safety profiles, FDA advisors said.

There was no formal vote on the topic at the Feb. 10-11 joint meeting of the Arthritis Advisory Committee and...

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