In the largest settlement over inappropriate drug marketing to date, drug giant Pfizer has agreed to pay $2.3 billion to settle a federal investigation into its off-label marketing of the since-recalled pain medication Bextra.
Though the FDA had only approved Bextra, a Cox-2 inhibitor, to treat common pain and inflammation, Pfizer illegally marketed it to treat acute surgical pain. In April 2005, Pfizer withdrew Bextra from the US market due to what the FDA found to be an increased risk of heart attack and stroke as well as the risk of a serious and occasionally fatal skin reaction.
The Pfizer settlement dwarfs the recent $1.42 billion Eli Lilly agreed to pay for marketing violations in connection with the antipsychotic Zyprexa, which has serious side effects and is only FDA approved to treat individuals with schizophrenia and severe bipolar disorder. From 2000 to 2003, however, Eli Lilly encouraged doctors to prescribe Zyprexa to patients with age-related dementia or mild bipolar disorder.
Earlier this week, Pfizer announced it would acquire drug rival Wyeth, maker of the drug Phenergan, for $68 billion. Phenergan garnered much negative attention during the case of Wyeth v. Levine, for its elevated risk of gangrene when improperly administered.