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Alert for Healthcare
Professionals
Valdecoxib (marketed as Bextra)
FDA Alert [4/7/2005]:
FDA has requested that Pfizer voluntarily withdraw Bextra from
the United States market. Pfizer has agreed to suspend sales and
marketing of Bextra in the United States, pending further
discussion with the Agency. At this time, the Agency has
concluded that the overall risk versus benefit profile of Bextra
is unfavorable. This conclusion is based on the potential
increased risk for serious cardiovascular (CV) adverse events,
which appears to be a class effect of non-steroidal
anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased
risk of serious skin reactions (e.g., toxic epidermal necrolysis,
Stevens-Johnson syndrome, erythema multiforme) compared to other
NSAIDs, and the fact that Bextra has not been shown to offer any
unique advantages over the other available NSAIDs.
This information reflects FDA’s
current analysis of all available data concerning this drug. FDA
intends to update this sheet when additional information or
analyses become available.
Recommendations
Data Summary
-
Bextra has been demonstrated to be associated with
an increased risk of serious adverse CV events in two short-term
trials in patients immediately post-operative from coronary artery
bypass graft (CABG) surgery. Data are not available from long-term
controlled clinical trials to evaluate the cardiovascular safety of
Bextra following chronic use. FDA has concluded that it is
reasonable to extrapolate the adverse CV risk information for Bextra
from the short-term CABG trials to chronic use given the fact that
other COX-2 selective NSAIDs have been shown in long-term controlled
clinical trials to be associated with an increased risk of serious
adverse CV events (e.g., death, MI, stroke), and the well described
risk of serious, and often life-threatening gastrointestinal
bleeding.
-
Bextra is a sulfonamide and already carries a boxed
warning in the package insert for serious and potentially
life-threatening skin reactions (e.g., toxic epidermal necrolysis,
Stevens-Johnson syndrome, erythema multiforme). The reporting rate
to FDA’s spontaneous reporting system for these serious skin
reactions is significantly greater for Bextra than other COX-2
selective agents. The risk of these serious skin reactions in
individual patients is unpredictable, occurring in patients with and
without a history of sulfa allergy, and after both short- and long
term use.
-
To date, there have been no studies that demonstrate
an advantage of Bextra over other NSAIDs that might offset the
concern about these serious skin risks, such as studies that show a
GI safety benefit, better efficacy compared to other products, or
efficacy in a setting of patients who are refractory to treatment
with other products.
-
Extensive data related to the cardiovascular safety
of Bextra and other COX-2 selective and non-selective NSAIDs were
presented at the Joint Meeting on February 16, 17, and 18, 2005, of
the Arthritis Advisory Committee and the Drug Safety and Risk
Management Advisory Committee. This information is available on the
following website:
http://www.fda.gov/ohrms/dockets/ac/cder05.html#ArthritisDrugs
Report serious adverse events to FDA's MedWatch at
1-800-FDA-1088; or
www.fda.gov/medwatch/report/hcp.htm
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or
301-827-4570
druginfo@fda.hhs.gov
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Date created: April 7, 2005 |
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