Seroquel Settlement for $520M Reached with Federal Prosecutors
Published: October 30th, 2009 • Comments: 5
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.
Comment by Yolanda on 1 November 2009:
I have developed acute pancreatitis as a result of taking Seroquel, I don’t see why it is still given even to infants when the side effects are so overwhelming, obviously the FDA allows the use and lets the BIG pharmaceurical$ companie$ get away with it why? I hope the lawyers in the class action suit win and let all of us affected have some kind of compensation. No matter what, they’ll keep pushing the drugs anyways, it’s all about money, to them, not the safety or welfare of patients, who wants to lose business?
Comment by Alvin on 2 November 2009:
I am with you, Yolanda. How can they get away with giving this drugs to kids? It’s marketing. No state Medicaid program should be paying for these drugs for kids, since they are not FDA-approved for kids. But the great marketing–which insists they are wonder drugs with no side effects–was apparently very persuasive to our state government pinheads, who took it hook, line and sinker (and probably took a few drug company perks, too).
Comment by Laverne on 13 November 2009:
Is it too late to join the seroquel class action lawsuit?
Comment by john on 13 January 2010:
I been off of seroquel for four years and I still have to stick to rigid diet because of the accute hypoglicima due to pancrease damage from seroquel.
Comment by Beverly on 20 February 2010:
I got involved in Seroquel lawsuit in 2008. The lawyers I filed wiith are in Texas. I live in Ohio. I have been trying to get information about what is going on and my lawyer won’t return my phone calls.