Pfizer Separately Agrees to Suspend Sales of Bextra Due to FDA Evaluation of
                   Risks of Rare But Serious Skin Reactions

    NEW YORK, April 7 /PRNewswire/ -- Pfizer said today it will work with the
U.S. Food and Drug Administration (FDA) to add expanded risk information in
the Celebrex label following an FDA decision announced this morning to require
boxed warnings of potential cardiovascular risk for all COX-2 pain relievers
and all NSAIDs, including older non-specific drugs such as ibuprofen and
naproxen.
    The boxed warning for all non-steroidal anti-inflammatory drugs (NSAIDs),
including Celebrex, will also contain information regarding gastrointestinal
risk that is already included elsewhere in their current labels.
    In addition, the FDA is asking manufacturers of all over-the-counter
NSAIDs to revise their labeling to include more information on the
cardiovascular and gastrointestinal risks as well as a warning about potential
skin reactions.
    Pfizer and the FDA plan further discussions regarding the precise content
of the Celebrex label. Pfizer has accumulated extensive Celebrex clinical data
over the past 10 years involving more than 40,000 patients. Pfizer also
reaffirmed its commitment to conduct additional long-term clinical studies
evaluating the benefits and risks of Celebrex.
    Pfizer also said it will work closely with the FDA to develop a guide to
assist patients and their healthcare professionals in making the best
decisions for treating their arthritis pain.
    Regarding Bextra, Pfizer's other oral Cox-2 inhibitor, the FDA informed
Pfizer late yesterday that, in the agency's view, Bextra's cardiovascular risk
could not be differentiated from other NSAIDs.  However, the agency has
concluded that the additional, increased risk of rare but serious skin
reactions associated with Bextra, already described in its label, warrants its
withdrawal from the market.
    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.
    In addition, at the request of European regulators, Pfizer will also
suspend sales of Bextra in the European Union.  The company is in contact with
other regulatory agencies around the world and will take appropriate measures
based on those discussions.
    Pfizer was informed by the FDA of its conclusions regarding Celebrex and
Bextra on Wednesday afternoon, one day after the company held a meeting with
financial analysts.  Pfizer received the request from the European regulators
early Thursday morning.  Pfizer said it is evaluating the operational and
financial impact of these actions.

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http://www.prnewswire.com/comp/688250.html
CONTACT:
Mariann Caprino, +1-212-733-4554, or Paul
Fitzhenry, +1-212-733-4637, both for Pfizer

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