Pfizer's Celebrex, Bextra Targets Of Public Citizen Withdrawal Petition
This article was originally published in The Pink Sheet Daily
Public Citizen tells FDA that COX-2 inhibitors have inherent cardiovascular risks and offer no efficacy advantages over non-selective NSAIDs. The group suggests the mechanism that creates the COX-2 inhibitors' thrombogenicity is "increased platelet-vessel wall interactions and firm adhesions."
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A study of celecoxib in Alzheimer's disease patients showed a statistically significant increase in cardiovascular events versus placebo. The study data are posted on PhRMA's clinicalstudyresults.org website, but Public Citizen alleges Pfizer recently revised the posting and questions when the data were submitted to FDA.
FDA advisory committees will consider overall benefit-risk of COX-2s and related products, both gastrointestinal safety and cardiovascular effects. The meeting will be held Feb. 16-18.
The watchdog group plans to file a petition in the next week calling for the withdrawal of Pfizer's COX-2 inhibitors. Celebrex and Bextra are among 180 currently marketed drugs Public Citizen advises consumers "do not use" on its expanded worstpills.org website.