| On 2-1-05 the Pharmacy Benefits Advisory Committee (PBAC) voted to remove Bextra® from coverage for the University of Michigan Employees Prescription Plan due to safety concerns. www.umich.edu/~benefits/plans/drugs/updates/cox2safety.htm
On 4-7-05 Pfizer announced that it will voluntarily withdraw Bextra® after the FDA concluded that overall risks exceed benefits.
This FDA request was based on:
- the lack of adequate data on the cardiovascular safety of long-term use of Bextra®, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery trials
- reports of serious and potentially life-threatening skin reactions (Stevens-Johnson syndrome)
- the lack of any demonstrated advantage of Bextra® compared with other NSAIDS
The FDA is asking manufacturers of prescription NSAIDS, including Celebrex® (celecoxib), to revise their labeling to include:
- a boxed warning, highlighting the increased risk of CV events and potential life-threatening gastrointestinal (GI) bleeding associated with their use
The FDA is asking manufacturers of non-prescription NSAIDS to revise their labeling to include:
- more specific information about the potential CV and GI risks
- stronger reminder to limit the treatment dose and duration as listed in the package insert
- a warning about potential skin reactions
Additional information regarding the FDA's requests on COX-2 selective drugs and non-selective NSAIDS can be found at:
http://www.fda.gov/cder/drug/infopage/COX2/default.htm
http://www.fda.gov/cder/drug/infopage/COX2/COX2qa.htm
http://www.fda.gov/bbs/topics/news/2005/NEW01171.html
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