Benefits Plans - Prescription Drug Plan: Drug Plan Updates and New Drug Releases -
Bextra® Removed From the Market Due To Safety Concerns

Page last updated: Wednesday, 26-May-2010 20:51:19 EDT

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. benefits.umich.edu/plans/drugs/updates/cox2safety.html

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

Limitations
The University of Michigan in its sole discretion may modify, amend, or terminate the benefits provided with respect to any individual receiving benefits, including active employees, retirees, and their dependents. Although the university has elected to provide these benefits this year, no individual has a vested right to any of the benefits provided. Nothing in these materials gives any individual the right to continued benefits beyond the time the university modifies, amends, or terminates the benefit. Anyone seeking or accepting any of the benefits provided will be deemed to have accepted the terms of the benefits programs and the university's right to modify, amend or terminate them.