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Bextra
Moratorium on New Starts & Conversion of Existing Patients
Kaiser Permanente Pharmacies in California to Stop Dispensing Bextra
Because of the significant concerns raised about the cardiovascular safety of Bextra, the
Physician Chiefs of the Kaiser Permanente Regional Pharmacy and Therapeutics
Committees, along with The Permanente Medical Group & South California Permanente
Medical Group Chiefs of Rheumatology, have agreed that Bextra should no longer be
prescribed and that existing patients using Bextra (valdecoxib) should be converted to
safer alternatives. As part of this effort, Kaiser Permanente pharmacies in California will
cease filling prescriptions for Bextra and prescribers will be contacted with suggested
alternatives. In Kaiser Permanente Regions outside of California, all new prescriptions
for Bextra will be reviewed and a physician driven conversion program to convert
existing Bextra prescriptions to safer alternatives will be instituted. This moratorium on
dispensing Bextra will last for at least 6 months, or until the FDA and/or Pfizer can
provide substantiated evidence to support the cardiovascular safety of this powerful
COX-2 inhibitor.
The evidence that led to this decision is compelling. The risks associated with a similar
COX-2 inhibitor Vioxx are unequivocal. In fact in an elderly population at high risk for
cardiovascular disease the estimated number needed to harm at high dose (50mg/d)
Vioxx is 20. In other words for every 20 people treated for one year in this high risk
population with Vioxx 50mg/d one patient will suffer a myocardial infarction. Even if
Bextra has only half the risk associated with it as Vioxx, Kaiser Permanente clinical
experts agree that the risk is too great, given the modest benefit provided by the drug.
There have also been a number of studies addressing Bextra that have raised serious
concerns about the drug’s safety profile. The first by Ott et al looking at 462 CABG
patients found a two fold increase in cardiovascular events in those treated with Bextra
(valdecoxib). The size of the study prevented it from reaching statistical significance. A
second study (abstract) presented at the American Heart Association in November 2004
and just published in Circulation by Garret FitzGerald and Curt Furberg looked at a
pooled analysis 1400 CABG patients treated with Bextra. That study demonstrated a 3
fold increase in risk.
Others have voiced similar concerns. In a December 23rd New England Journal of
Medicine editorial, Wayne Ray recommended that physicians “Stop prescribing Bextra
except under extraordinary circumstances”.
The safety of medications prescribed to our patients is Kaiser Permanente’s prime
concern in taking this action. There are many safe alternatives to use in our patients
suffering with pain. The apparent risks associated with strong COX-2 inhibition make
continued use of Bextra problematic. In addition to not filling new prescriptions, Kaiser
Permanente will be working with the physicians of patients on existing Bextra therapy to
identify medically appropriate alternatives. Kaiser Permanente looks forward to the
deliberation of FDA’s advisory committee Feb 16th- 18th in hopes for further clarity on
this controversial issue and will reconsider it’s position if convincing evidence about
Bextra’s safety is provided.