Bextra: Example of Poor FDA Regulation

Bextra (valdecoxib-NSAID) is an example of dangerously poor FDA regulation, according to the testimony of Sidney M. Wolfe, MD Director of the Public Citizen’s Health Research Group (HRG), before the Health Subcommittee of the House Energy and Commerce Committee Hearing on Current Issues Related to Medical Liability Reform on February 10, 2005.

"When we learned almost two years ago that FDA had rejected Pfizer’s application for a new pain indication for Bextra, the agency, in collaboration with Pfizer, denied our freedom of information request for the FDA review as to why the application had been rejected.

We thus had to sue the FDA to obtain these data," Wolfe stated.

The medical officer who reviewed the study stated that “The excess of serious cardiovascular thromboembolic [blood clots] in the valdecoxib arm of the CABG [Coronary Artery Bypass Graft] trial is of note as the entire study population received prophylactic low dose aspirin as part of the standard of care in this setting to minimize just such events.

Given the emerging concern over a possible pro-thrombotic action of certain agents in the COX2 class, these data are of concern.”

Act now! It is essential that you inquire about your case as soon as possible. Litigation may be the only way to receive the damages to which you may be entitled, such as medical and health care bills, lost or diminished wages, and financial compensation to family in the case of death. Your individual state's law may limit your time to bring a legal claim to protect your rights. You need to have your Bextra claim evaluated immediately!

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see also:

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