September 17th, 2009FDA asks Pfizer to withdraw Bextra and add boxed warning to Celebrex
FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the entire risk versus benefit
profile for the drug is unfavorable. FDA has also asked Pfizer to contain a boxed augury in the Celebrex (celecoxib) brand.
The Food and Stimulant Administration (FDA) today announced a series of important changes pertaining to the marketing of the
non-steroidal anti-rabid class of drugs, including COX-2 selective and medication and non-medication
(over-the-counter (OTC)) non-discriminatory NSAID medications. A list of these products is available on the Internet at fda.gov/cder/drug/infopage/cox2/default.htm.
“Today’s actions protect and ahead of the vigour of the millions of Americans who rely on these drugs everyday,” said Dr.
Steven K. Galson, Acting Chairman of FDA’s Center for Drug Evaluation and Probing (CDER). “FDA is providing the out of the closet
information based on the latest at one’s fingertips scientific data to teach the meticulous and appropriate use of these drugs aimed at
maximizing their dormant benefits and minimizing their risks.”
Pfizer has agreed to delay sales and marketing of Bextra in the U.S., pending further discussions with the activity. Pfizer
has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other direction NSAIDs
to correct their labels to file the same boxed portent highlighting the hidden for increased risk of cardiovascular (CV)
events and gastrointestinal (GI) bleeding associated with their press into service. Manufacturers of Celebrex and all other prescription
NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to expropriate make them aware of the
potential for CV and GI adverse events associated with the use of this class of drugs.
In additionally, FDA is asking the manufacturers of all OTC NSAIDs to revamp their labels to count more well-defined info
about the capacity CV and GI risks, and poop 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 formula NSAIDs
already addresses potential strip reactions.
This current reexamination of the CV risks of NSAIDs began after Merck conducted a unbidden worldwide withdrawal of its
COX-2 demanding 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 details, including figures accumulated since the drugs were approved. The FDA
has carefully considered the presentations, discussions, and recommendations from the dive meeting of the Agency’s Arthritis
and Numb Cover and Risk Management Notice Committee held on February 16-18, 2005.
To inform the catholic and healthcare community of its decisions, FDA today issued a Social Health Admonition (PHA) and updated
compliant and healthcare practitioner inside info sheets.
Additional report more today’s announcements is nearby on FDA’s Web site at http://www.fda.gov/cder. Information can also be obtained by job 1-888-INFO-FDA (888-463-6332).
fda.gov/bbs/topics/news/2005/NEW01171.html
Observation drug word on Bextra; Vioxx.
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