April 7, 2005
The Food and Drug Administration (FDA) today announced a series of
important changes pertaining to the marketing of the non-steroidal
anti-inflammatory class of drugs, including COX-2 selective and
prescription and non-prescription (over-the-counter (OTC))
non-selective NSAID medications. A list of these products is
available on the Internet at
http://www.fda.gov/cder/drug/infopage/cox2/default.htm.
"Today's actions protect and advance the health of the millions
of Americans who rely on these drugs everyday," said Dr. Steven K.
Galson, Acting Director of FDA's Center for Drug Evaluation and
Research (CDER). "FDA is providing the public information based on
the latest available scientific data to guide the careful and
appropriate use of these drugs aimed at maximizing their potential
benefits and minimizing their risks."
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FDA has asked Pfizer, Inc. to
withdraw
Bextra (valdecoxib) from the market because the overall
risk versus benefit profile for the drug is unfavorable. FDA
has also asked Pfizer to include a boxed warning in the
Celebrex (celecoxib) label. Pfizer has agreed to suspend
sales and marketing of Bextra in the U.S., pending further
discussions with the agency. Pfizer has agreed to work with
FDA on the boxed warning for Celebrex. FDA is asking
manufacturers of all other prescription NSAIDs to revise
their labels to include the same boxed warning highlighting
the potential for increased risk of cardiovascular (CV)
events and gastrointestinal (GI) bleeding associated with
their use. Manufacturers of Celebrex and all other
prescription NSAIDs will be asked to revise their labeling
to include a Medication Guide for patients to help make them
aware of the potential for CV and GI adverse events
associated with the use of this class of drugs. |
In addition, FDA is asking the manufacturers of all OTC NSAIDs to
revise their labels to include more specific information about the
potential CV and GI risks, and information to assist consumers in
the safe use of the drugs. FDA is also asking manufacturers of OTC
NSAIDs to include a warning about potential skin reactions. The
labeling of the prescription NSAIDs already addresses potential skin
reactions.
This current reexamination of the CV risks of NSAIDs began after
Merck conducted a voluntary worldwide withdrawal of its COX-2
selective NSAID,
Vioxx (rofecoxib), in September 2004. FDA will carefully review
any proposal from Merck for resumption of marketing of Vioxx.
These actions are based on the available scientific data,
including data accumulated since the drugs were approved. The FDA
has carefully considered the presentations, discussions, and
recommendations from the joint meeting of the Agency's Arthritis and
Drug Safety and Risk Management Advisory Committee held on February
16-18, 2005.
To inform the public and healthcare community of its decisions,
FDA today issued a Public Health Advisory (PHA) and updated patient
and healthcare practitioner fact sheets. |