| On September 30, 2004, Vioxx®, a COX-2 inhibitor that is frequently used for arthritis pain, was withdrawn from the market because of the increased rate of cardiovascular adverse events. Since September 30th, safety concern information regarding Bextra®, another COX-2 medication, has become available.
In October, a “Dear Doctor” letter was sent by the FDA to physicians describing the warnings regarding a rare but very serious skin reaction potential with Bextra®. The skin reaction warning has also been added to the labeling provided to physicians and pharmacists. The “Dear Doctor” letter also contained information on the increased risk in coronary artery bypass graft surgery patients.
There are currently 2 medications available in the COX-2 classification, since the Vioxx® withdrawal, Celebrex® and Bextra®. Questions have been raised as to whether the cardiovascular safety issues are a result of a COX-2 mechanism of action or just specific to Vioxx®, however the question remains unanswered. Bextra® was one of the products recently identified as having unresolved safety concerns during a Senate Finance Committee Hearing. The cardiovascular safety of Celebrex® has been supported by an FDA/Kaiser Permanente retrospective study.
The FDA’s Arthritis Drugs and Drug Safety & Risk Management Advisory Committees is scheduled to meet jointly in February 2005 to review the COX-2 class of medications.
The physicians and pharmacists of the University of Michigan Pharmacy Benefit Advisory Committee made the decision to remove Bextra® coverage effective 2-1-05 because of these safety concerns. Bextra® 10mg will not be covered under the University of Michigan prescription benefit plan as of 2-1-05. University of Michigan prescription plan members may obtain coverage for Bextra® 20mg only with prior authorization and only for primary dysmenorrhea, with quantity limitations.
University of Michigan Prescription plan members currently taking Bextra® will receive a letter from Caremark® explaining the non-covered status of Bextra®. Members currently taking Bextra® should discuss the new safety concerns and coverage change with you physician. You and your doctor may consult the University of Michigan Formulary or the University of Michigan Preferred Drug List at the Benefits Office Web site: www.umich.edu/~benefits/plans/drugs for a list of alternative covered medications.
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