Important Information You Need To Be Aware Of Prior
to using NSAId's such as Advil and Motrin:
Medical authorities continually caution physicians and patients with
regards to the use of non-steroidal anti-inflammatory pain relievers
known as NSAIDs.
These pain relievers such as aspirin, ibuprofen, naproxen sodium,
etc... are believed to be responsible for more than 76,000
hospitalizations each year due to gastrointestinal bleeding. An
estimated 41,000 hospitalizations and 3,300 deaths involving the
elderly are attributed annually to NSAIDs.
|Ibuprofen in heart attack
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|FDA Announces Series of
Changes to the Class of
Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) |
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
"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."
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
[Back to Top of Page]
Announces Changes for All NSAIDs; Bextra
Withdrawn From Market |
Why Has Bextra Been Singled
What Should Patients Do Who Take Bextra
Or Other NSAIDs?
[Back to Top of Page]
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