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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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