According to a quarterly report released by AstraZenca, the drug maker has reached an agreement in principal to pay $520 million to settle a Seroquel probe by the U.S. Attorney’s Office in Philadelphia over their alleged off-label promotion of the atypical antipsychotic drug for uses that were not established as safe and effective through the FDA approval process.
The pharmaceutical company announced the Seroquel settlement this week to resolve the investigation by federal prosecutors, subject to finalization of other agreements, including “civil settlement agreements and a corporate integrity agreement.”
Seroquel (quetiapine fumarate) is an atypical-antipsychotic which was approved for treatment of schizophrenia in 1997. Although a new extended release version was approved last year for treatment of bipolar disorders, Seroquel has been widely prescribed off-label for a variety of conditions that the FDA had not established were safe and effective, such as treatment of anxiety, obsessive compulsive disorders, dementia, insomnia and autism.
While doctors are free to prescribe medications for non-approved uses, pharmaceutical companies are barred from promoting such off-label prescriptions.
According to internal company documents uncovered through Seroquel litigation, off-label promotion of the drug has been a key marketing strategy for AstraZenca since at least 2000. During pretrial proceedings in lawsuits involving Seroquel filed by consumers who developed diabetes and other health problems after using the drugs, company papers were released that had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.
Thousands of people have filed a Seroquel lawsuit against AstraZeneca alleging that the drug maker failed to adequately warn about the increased risk of diabetes, which is caused by the drug’s weight gain side effects. The drug has also been linked to an increased risk of pancreatitis and a movement disorder known as tardive dyskinesia.
All federal Seroquel cases are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.
The details of the Seroquel settlement agreement with federal attorneys have not been released, and it is unknown whether AstraZeneca would admit any wrongdoing as part of the settlement. The federal investigations also include a probe of some physicians who were part of Seroquel’s clinical trials, but it is unclear whether the settlement addresses those or not.