Pfizer Inc., manufacturer of Bextra, will pay $2.3 billion to settle a federal investigation over the company's off-label promotion of the prescription painkiller, which was pulled from the market in 2005.
Bextra (valdecoxib) was intended to relieve symptoms of osteoarthritis and rheumatoid arthritis in adults, but was pulled from the market in 2005 because of links to serious cardiovascualar problems in users of the drug. According to the Wall Street Journal, "[i]t isn't clear what off-label uses Pfizer's marketing of Bextra allegedly involved," although "pt]he company settled another case in October in which the Kentucky state attorney general complained that Pfizer promoted Bextra for acute and surgical pain, despite lacking approval for such uses."
News of Monday's record settlement agreement was lost in the shuffle over Pfizer's announcement of its $68 billion takeover of Wyeth Pharmaceuticals earlier this week. If the settlement agreement is approved in federal court, the $2.3 billion would be the largest amount ever paid by a drug company to resolve charges of wrongdoing over the marketing of pharmaceuticals. Pfizer's announcement of the Bextra settlement agreement on Monday came just a few weeks after Eli Lilly & Co. pled guilty to illegally marketing the antipsychotic drug Zyprexa, and agreed to pay $1.42 billion to settle a federal suit in Pennsylvania federal court.