[e-drug] FDA action on Cox-2 NSAIDs; valdexocib withdrawal

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: FDA action on Cox-2 NSAIDs; valdexocib withdrawal
---------------------------------------------------------

FOR IMMEDIATE RELEASE      Media Inquiries:   Kathleen Quinn
P05-17                                          301-827-6242
April 7, 2005              Consumer Inquiries:  888-INFO-FDA


FDA ANNOUNCES SERIES OF CHANGES TO THE CLASS OF MARKETED NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDs)

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 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 (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 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.

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).
####