MedWatch - The FDA Safety Information and Adverse Event
Reporting Program
After concluding that the overall risk versus benefit
profile is unfavorable, FDA has requested Pfizer, Inc.
to voluntarily withdraw Bextra (valdecoxib) from the
market. This request is 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 (CABG) trials that FDA
believes may be relevant to chronic use.
- Reports of serious and potentially life-threatening
skin reactions, including deaths, in patients using
Bextra. The risk of these reactions in individual patients
is unpredictable, occurring in patients with and without
a prior history of sulfa allergy, and after both
short- and long-term use.
- Lack of any demonstrated advantages for Bextra compared
with other NSAIDs.
Patients currently taking Bextra should contact their
physicians to consider alternative treatments.
The FDA is also asking manufacturers of all marketed
prescription NSAIDs, including Celebrex (celecoxib),
a COX-2 selective NSAID, to revise the labeling
(package insert) for their products to include a boxed
warning and a Medication Guide. The boxed warning will
highlight the potential for increased risk of CV events
with these drugs and the well-described, serious, and
potentially life-threatening gastrointestinal (GI) bleeding
associated with their use. The Medication Guide will
accompany every prescription NSAID at the time it is
dispensed to better inform patients about the CV and
GI risks.
Finally, the FDA is asking manufacturers of non-prescription,
over-the-counter (OTC) NSAIDs to revise their labeling
to include more specific information about the potential
GI and CV risks, and information to assist consumers
in the safe use of the drug. This announcement does not
apply to aspirin as it has clearly been shown to reduce
the risk of serious adverse CV events in certain patient
populations.
Read the complete MedWatch 2005 Safety Summary, with
links to the Public Health Advisory, Press Release
and Questions and Answers at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Bextra