|
E-mail this page to a friend!
Pfizer Takes Bextra Off Market at FDA Request
Agency orders new warning labels on Cox-2 and other
NSAID medications
April 7, 2005 The Food and Drug Administration
today asked Pfizer to withdraw Bextra from the market and announced new
label warnings for 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.
|
Related Story |
|
|
FDA Delays Action on Celebrex, Waiting for More
Info
Dec.
18, 2004 Late yesterday the Food and Drug Administration issued a
statement on the warning issued by Pfizer of possible heart problems caused
by their drug Celebrex, which is taken my millions of senior citizens for
pain relief, primarily that caused by arthritis. The FDA says they are
taking no regulatory action now but will seek more information.
More... 12/18/04*
|
|
"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."
A list of these products is available on the
Internet -
Click
Here.
FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib)
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 also agreed to work with FDA on the boxed warning for Celebrex.
Pfizer issued the following statement: Pfizer
respectfully disagrees with FDA's position regarding the overall
risk/benefit profile of Bextra. However, in deference to the agency's
views, the company has agreed to suspend sales of the medicine pending
further discussions with the FDA. Pfizer said it will explore options
with the agency under which the company might be permitted to resume
making Bextra available to physicians and patients. For now, patients
should stop taking Bextra and contact their physicians about appropriate
treatment options.
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
said it 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.
Additional information about today's announcements
is available on FDA's Web site at
www.fda.gov/cder. Information can also be obtained by calling
1-888-INFO-FDA (888-463-6332).
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
