NEW YORK, Oct. 15 /PRNewswire-FirstCall/ -- In view of the increased focus
on alternative treatment options for people with arthritis, Pfizer is
providing information to healthcare professionals about its COX-2 product
Bextra(R) (valdecoxib).
    "Bextra is an important treatment option for patients faced with
debilitating and chronic pain associated with osteoarthritis and rheumatoid
arthritis," said Joseph Feczko, MD, Pfizer's president of worldwide
development. "At the same time, as is true with any medicine, all benefits and
risks need to be considered by physicians when treating their patients.  This
communication is intended to reinforce our commitment to share information
with physicians about our product."
    Since 2002, the Bextra product label has included information regarding
the risk of a very rare but serious skin reaction.  The risk of this skin
reaction exists with many other medications. Based on additional spontaneous
event reporting data, this risk exists with Bextra primarily within the first
two weeks of therapy and, while very rare, at a reported rate greater than
other COX-2 products, such as Celebrex.  Pfizer is working with regulatory
authorities around the world to update the Bextra product label. In the letter
to healthcare professionals, Pfizer also reviewed information about the
cardiovascular profile of Bextra.  The information is based on analyses of a
comprehensive clinical trial database of nearly 8,000 patients treated with
Bextra for durations ranging from six to 52 weeks. Available clinical
information for Bextra suggests there is no increased risk of cardiovascular
thromboembolic events in people treated for osteoarthritis (OA) and rheumatoid
arthritis (RA).
    In addition, Bextra has been studied in several surgical settings. In
studies in general surgery, Bextra in combination with the investigational
drug parecoxib (an IV formulation) showed no increased risk of cardiovascular
thromboembolic events. However, in two trials in a high-risk surgery known as
coronary artery bypass graft (CABG), an increase in cardiovascular events was
observed in patients receiving Bextra alone or in combination with parecoxib.
The first study was published last year(1) and the second study was just
recently completed. Pfizer emphasized that Bextra is not approved for use in
any surgical setting in the United States.
    Pfizer will be conducting further studies to confirm the long-term
cardiovascular safety profile of Bextra in patients who require chronic
treatment for arthritis with a COX-2-specific inhibitor.
    Bextra is indicated for the relief of signs and symptoms of osteoarthritis
and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea.
Bextra was approved and introduced in the U.S. market in 2001.

    (1) Ott E, Nussmeier N, Duke P, et al. Efficacy and safety of the
        cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients
        undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg.
        2003 Jun;125(6):1481-92

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CONTACT:
Susan Bro, +1-212-733-5554 or Andy McCormick,
+1-212-733-5469, both of Pfizer Inc

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