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# Celebrex Passes FDA-ordered Safety Study: Pfizer
- URL: https://www.fdaweb.com/celebrex-passes-fda-ordered-safety-study-pfizer/
- Published: 2016-11-14T12:00:00.000Z
- Updated: 2026-09-14T21:47:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137337

An FDA-ordered safety study of Pfizer’s arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of osteoarthritis or rheumatoid arthritis, were at high risk for cardiovascular disease, and required daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to control symptoms of arthritis. Published in the *New England Journal of Medicine*, the [study](http://www.nejm.org/doi/full/10.1056/NEJMoa1611593?rss=searchAndBrowse&ref=fdaweb.com#t=articleTop) showed that “patients treated with celecoxib experienced significantly fewer gastrointestinal events as compared with those receiving prescription doses of ibuprofen or naproxen,” Pfizer says. “The PRECISION trial helps to refute the assumption held by many physicians that naproxen treatment results in better cardiovascular outcomes as compared to other NSAIDs, including celecoxib. It is important to note that given the trial’s design – prescription doses and chronic use in patients with cardiovascular risk factors – no inferences are possible regarding the safety of intermittent use of low-dose, over-the-counter NSAIDs.”