Pfizer Sees Increased Cardiovascular Risk With Bextra After Bypass Surgery
This article was originally published in The Pink Sheet Daily
Executive Summary
Two studies on short-term use of a parecoxib/Bextra treatment regimen following coronary artery bypass graft surgery showed an increased risk of cardiovascular events. Pfizer discusses the surgery study results as part of a "Dear Health Care Professional" letter about skin reactions associated with Bextra.
You may also be interested in...
Bextra Meta-Analyses Could Be Taken Up At February COX-2 Advisory Cmte.
Drug safety committee member Curt Furberg's meta-analysis suggests increased risk of cardiovascular events for patients with osteoarthritis and rheumatoid arthritis taking Bextra versus placebo while Pfizer points to a meta-analysis of 8,000 patients that did not show an effect. Furberg disinvited by FDA to participate in committee meeting following public comments.
Bextra Meta-Analyses Could Be Taken Up At February COX-2 Advisory Cmte.
Drug safety committee member Curt Furberg's meta-analysis suggests increased risk of cardiovascular events for patients with osteoarthritis and rheumatoid arthritis taking Bextra versus placebo while Pfizer points to a meta-analysis of 8,000 patients that did not show an effect. Furberg disinvited by FDA to participate in committee meeting following public comments.
Bextra "Likely" To Add Black Box Warning, Pfizer Says
Pfizer expects that resolution of labeling discussions with FDA will include boxed warning about skin reactions. FDA will have to consider whether to handle issue in context of broader COX-2 class safety review.