Pfizer Suspends Sales of Bextra (cont.)
We anticipate that our actions will lead to careful and appropriate use of
these drugs to maximize their potential benefits and minimize their risks.
2. To what products does FDA's decision apply and what is being requested?
The decision applies to the marketed COX-2 selective drugs (Bextra and
Celebrex) as well as the non-selective NSAIDs. A detailed chart listing the
chemical name and trade names for the products affected by this announcement is
attached and also can be found at
For the COX-2 selective inhibitor drugs, we have determined the following:
- Bextra (valdecoxib tablets): FDA has concluded that the overall risk versus
benefit profile is unfavorable at this time and has requested the manufacturer
of Bextra, Pfizer, Inc., to voluntarily withdraw Bextra 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
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 serious skin 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, and
- the lack of any demonstrated advantages for Bextra compared with other
Pfizer has agreed to suspend sales and marketing of Bextra in the U.S.
pending further discussions with the agency.
- Celebrex (celecoxib tablets): We have concluded that the benefits of Celebrex
outweigh the potential risks in properly selected and informed patients. FDA has
decided to allow Celebrex to remain and has asked Pfizer to take the actions
- Revise the Celebrex label to include a boxed
warning containing the class NSAID warnings and contraindication about CV
and GI risk, plus specific information on the controlled clinical trial data
that demonstrate an increased risk of adverse CV events for celecoxib.
- Encourage practitioners to use the lowest effective
dose for the shortest duration consistent with individual patient treatment
- Include a Medication Guide as part of the labeling.
It will be required to be given at the time the drug is dispensed to inform
patients of the potential for CV and GI risk associated with NSAIDS, in
general, and Celebrex specifically. The Medication Guide will inform
patients of the need to discuss with their doctor the risks and benefits of
using NSAIDs and the importance of using the lowest effective dose for the
shortest duration possible.
- Commit to conduct a long-term study of the safety of Celebrex compared to
naproxen and other appropriate drugs.
- Vioxx (rofecoxib tablets and suspension): Vioxx was voluntarily removed from
the market by Merck in September 2004. FDA will carefully review any proposal
from Merck for resumption of marketing of Vioxx, and would likely discuss the
review with the new FDA Drug Safety Oversight Board and an Advisory Committee
before making a final decision.