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ATTORNEY GENERAL GANSLER SETTLES
WITH PFIZER, INC.
REGARDING MARKETING OF BEXTRA AND CELEBREX
Attorney
General Gansler and 32 other Attorneys General agree to a Consent
Judgment
Baltimore,
MD (October 22, 2008)-Attorney General Douglas F. Gansler announced
today that his Consumer Protection
Division,
along with
consumer protection agencies
from 31 other states and the District of Columbia, reached a settlement with
Pfizer, Inc. concerning the company’s promotion of the “Cox-2” drugs
Celebrex and Bextra. Attorney General Gansler and Pfizer agreed to a Consent
Judgment that was filed today in the Circuit Court for Baltimore City that concerned
Pfizer’s off-label marketing of Bextra and Celebrex for uses previously
rejected by the United States Food and Drug Administration (“FDA”).
“Pharmaceutical companies cannot market drugs to consumers for uses
that have not been approved by the FDA,” Attorney General Gansler stated. “This
settlement protects consumers from drugs being promoted for purposes rejected
by the FDA.”
The Attorney General alleged that
Pfizer engaged in a campaign to promote Bextra for uses that had been expressly
rejected by the FDA, including use
for acute and surgical pain relief, due to safety concerns. While a physician
is allowed to prescribe drugs for unapproved uses, pharmaceutical manufacturers
such as Pfizer are prohibited from marketing their products for uses that have
not been approved by the FDA (“off-label”). COX-2 drugs such as
Bextra and Celebrex are drugs that were developed to block the COX-2 enzyme
without blocking other enzymes that have a beneficial effect on the gastrointestinal
system. The Attorney General also alleged that Pfizer deceptively used research
data concerning its Celebrex product to explain the safety and efficacy of
Bextra. Bextra, Celebrex and other “Cox-2" drugs have been associated
with an increased risk of serious cardiovascular adverse events such as heart
attacks and strokes. Bextra also has been found to carry a risk of a serious
and sometimes fatal skin condition.
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