Seroquel Settlement for $520M Reached with Federal Prosecutors

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.

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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.

19 Comments

  • SolliahJune 14, 2023 at 6:05 pm

    This drug has ruined my life and my health.

  • LynnJuly 21, 2016 at 11:43 pm

    What atty work for to get you your check?i am looking for an atty here in Texas.i was on that for 4 years.i need help please.

  • CassSeptember 24, 2012 at 2:34 am

    This doctor at a Rehab at St.David's hosptial gave my love one this SEROQUEL Drug after she had brain surgery, this drug caused so many problems, when it was not even needed, some of these doctors need to be sued because they know the side effects causes major problems.

  • CatherineSeptember 20, 2012 at 7:25 am

    I desperately need an attorney for my CHRONIC PANCREATITIS due to taking 600 mg of SEROQUEL since it came out! SEROQUEL cost me $800 plus every month from then til about 6 months ago! I want my money back! My hospital bills paid! Pain n suffering for almost a year and counting! PLEASE HELP ME! Catherine

  • MarvinJuly 13, 2012 at 5:05 am

    With BPB law firm. Waiting since February2012 For $9600 Medicare/Medicaid Holdback Tel:320 3098146 Any input Any Answers. When will receive the $$$$

  • Randal LJune 28, 2011 at 7:22 pm

    I joined in the lawsuit about a year ago here in Bama. A week ago I recv'd a letter from the attrny's detailing what my payout would be...BUT after attrny fee's expenses and THEN THE IDIOT'S HOLD BACK FOR MEDICIAID?????????? of which i HAVE NEVER HAD. I wound up w/ a paltry payout of a little over a thousand dollars from an original of almost $10,000.00. Which itself is not near enough to cover t[Show More]I joined in the lawsuit about a year ago here in Bama. A week ago I recv'd a letter from the attrny's detailing what my payout would be...BUT after attrny fee's expenses and THEN THE IDIOT'S HOLD BACK FOR MEDICIAID?????????? of which i HAVE NEVER HAD. I wound up w/ a paltry payout of a little over a thousand dollars from an original of almost $10,000.00. Which itself is not near enough to cover the medical issues i have had to deal with. This was simply another way for the lowlifes to get rich while the sufferer still suffers and gets absolutely nothing but peanuts.

  • chuckMay 30, 2011 at 2:08 pm

    I took seroquel and developed diabetes and a whole host of medical problems . I can' find an attorney to even tell me what to do or how to join in on a law suit . My medical situation is unstable and I can't find help .

  • larryMarch 26, 2011 at 3:05 pm

    i have been taking seroquel. i am blacking out and falling. i am afraid to see a doctor for fear of been diagnosed with diabetes or pancreatitus

  • patriciaMarch 24, 2011 at 9:48 pm

    I haven't heard anything from my lawyers for over 13 months. Moved to another state, left them my info, plus forwarding address.......NOTHNG> I have been searching for 3 months now, since MY papers got lost or destroyed in the move, TO LOCATE MY LAWYER AND/OR CASE NUMBER.......BEEN BOUNCED ALL OVER THIS UNITED STATES.......WHERE AM I, ANYBODY KNOW.......MY CONDITIION HAS WORSENED, NOW ON AN I[Show More]I haven't heard anything from my lawyers for over 13 months. Moved to another state, left them my info, plus forwarding address.......NOTHNG> I have been searching for 3 months now, since MY papers got lost or destroyed in the move, TO LOCATE MY LAWYER AND/OR CASE NUMBER.......BEEN BOUNCED ALL OVER THIS UNITED STATES.......WHERE AM I, ANYBODY KNOW.......MY CONDITIION HAS WORSENED, NOW ON AN INSULIN PUMP. CAN ANYONE IN A CASE THAT LIVES IN KENTUCKY OR INDIANA CONTACT ME WITH THEIR LAWYERS INFO........MAYBE I CAN BE LOCATED.......THANKS ! THE HUBBY SAYS IT'S ALL A SCAM TO GET OUR INFO........??????? WHO KNOWS?????

  • ToniMarch 19, 2011 at 2:05 pm

    My Lawyer's have offices in New York and Texas, and I didn't have my calls returned, but one day I got a call and I did receive letters asking crazy questions that I had already answered. But I was patient and I received my offer and now I will get a check. Hope you guys will be as fortunate

  • robertFebruary 25, 2011 at 9:19 pm

    info from texas is comming just talked to them.don't know how much if any money is comming sounds likes more paperwork..seroquil is aweful,the side effects are worse than the bi-polar,weight gain was aweful.took over a year to get back in shape

  • lageneFebruary 24, 2011 at 2:44 am

    my son was on seroquel in 2009 and 2010 i new othing .my son would complain he was so tierd all the time and now he does things why he is asleep that he never did before he took this med i had no idea this medicine was causeing these problems or i would had never let my son b put on seroquel i wish some one could give me more info thank you

  • AnnnetteJanuary 6, 2011 at 1:04 pm

    Beverly good lucky with gettig information out Texas.I live in Alabama I filed Texas at frist I could not get them to reture my calls.So I am changing lawyers.I am a type 2 diaetic Plus I had panictices and was real sick for sometime.

  • LindaJune 9, 2010 at 11:41 pm

    I started taking 50 mg. of Seroquel in 2004 for insomnia. I started having excessive movements. It wasn't until 2006 that a doctor suggested that Seroquel might be involved. I went off of it for 6 mos., but the movements continued, so I decided that it couldn't be caused by the Seroquel. Since it worked so well for sleep, my doctor put me back on it. After 2 brain scans and neuroloigical test[Show More]I started taking 50 mg. of Seroquel in 2004 for insomnia. I started having excessive movements. It wasn't until 2006 that a doctor suggested that Seroquel might be involved. I went off of it for 6 mos., but the movements continued, so I decided that it couldn't be caused by the Seroquel. Since it worked so well for sleep, my doctor put me back on it. After 2 brain scans and neuroloigical testing, I was told that the most likely cause was Seroquel and that it was permanent. I've been off of it for a year with no improvment. My neuroloigist said I had a form of Tardive Dyskinesia. They give me meds to help control the symptoms, but they only help a little. So now I am totally unable to work. I'm also very embarrassed by my movements in public. Doctors still give it out like candy for sleep. I hope they'll get the message that this drug should only be used, if there's no other alternative.

  • BeverlyFebruary 20, 2010 at 7:01 pm

    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.

  • johnJanuary 13, 2010 at 4:30 pm

    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.

  • LaverneNovember 13, 2009 at 5:44 pm

    Is it too late to join the seroquel class action lawsuit?

  • AlvinNovember 2, 2009 at 11:27 pm

    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 prob[Show More]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).

  • YolandaNovember 1, 2009 at 5:56 pm

    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 push[Show More]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?

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