Seroquel Lawsuit Uncovers Documents Suggesting Intention to Promote Off-Label

According to internal AstraZeneca documents obtained during the litigation over side effects of Seroquel, which has been linked to an increased risk of diabetes and other injuries, the drug maker discussed intentions to promote the medication for off-label uses.

Seroquel 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 AstraZeneca never established were safe and effective, such as treatment of anxiety, obsessive compulsive disorders, dementia, insomnia and autism.

Although doctors are free to prescribe any approved medication for non-approved uses, off-label marketing by drug makers is illegal and can result in heavy fines and penalties. Some estimates have suggested that as much as 70% of all Seroquel prescriptions were for unapproved uses, yet AstraZeneca has denied that they ever promoted it inappropriately.

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Private documents publicly released this week seem to suggest otherwise, indicating that off-label Seroquel promotion was a key marketing strategy for the drug maker as early as 2000.

One of the papers released 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.

Other documents released in March 2009, indicated that AstraZeneca was aware as early as 1997 that Serquel increased the risk of weight gain and diabetes. The pharmaceutical company attempted to indicate the drug was weight-neutral and doctors were told that there were no Seroquel diabetes problems, even though their own drug-safety acknowledged internally that there was evidence of a connection.

More than 15,000 people have filed lawsuits in state and federal courts throughout the United States against AstraZeneca alleging that they failed to adequately warn about the risk of serious Seroquel side effects, such as weight gain, hyperglycemia, diabetes and a rare movement disorder known as tardive dyskinesia. The documents were unsealed recently, allowing lawyers representing individuals in those lawsuits to publicly release the internal information before trial.

The first Seroquel lawsuit is scheduled for trial to begin June 29, 2009, in Delaware state court. The case involves claims by Nina Scaife, who developed diabetes after using the drug off-label for treatment of insomnia. All federal cases have been consolidated before one judge in an MDL, or multidistrict litigation, pending in the U.S. District Court for the Middle District of Florida.

10 Comments

  • patriciaApril 17, 2011 at 3:53 pm

    I'm 28 years old and my son jacob is 11 on seroquel now for about 2 years since he started he has gained 85 pounds keeping food from him is a chore he has constant cravings of hunger hords food and hides it I'm afraid of him contracting diabetes possibly the worst fear is he will get something worse. But i can not take him off DCFS tell me I have to have my child medicated or they will take [Show More]I'm 28 years old and my son jacob is 11 on seroquel now for about 2 years since he started he has gained 85 pounds keeping food from him is a chore he has constant cravings of hunger hords food and hides it I'm afraid of him contracting diabetes possibly the worst fear is he will get something worse. But i can not take him off DCFS tell me I have to have my child medicated or they will take my children for medical niglect me son is 11 autistic bipolar and skotzophrentit but honestly he is. Worse on the meds i dont know what to do at this point i feel hopeless that the drugging of children will end!!

  • KellyDecember 29, 2010 at 4:02 pm

    I was put on Seroquel XR for depression supposedly to help the Zoloft work better like Abilify. This happened in Feb. '10 when I was inpatient for suicidal ideation. I had been on Abilify and Zoloft and this psychiatrist who just met me and talked to me for 5 minutes suddenly took me off of Abilify and started me on Seroquel and Trazadone. Really? I didn't argue b/c I wasn't in a rational fram[Show More]I was put on Seroquel XR for depression supposedly to help the Zoloft work better like Abilify. This happened in Feb. '10 when I was inpatient for suicidal ideation. I had been on Abilify and Zoloft and this psychiatrist who just met me and talked to me for 5 minutes suddenly took me off of Abilify and started me on Seroquel and Trazadone. Really? I didn't argue b/c I wasn't in a rational frame of mind where I could make sound decisions for myself. After discharge I went to see my regular psychiatrist and she changed it to Seroquel XR and upped my dose from 300 to 600mg. Since then I gained over 45 pounds in 10 months! I'm obese for the first time in my life and all of this weight on my body is uncomfortable and embarrassing! This "Seroquel Hunger" has changed the way I eat by making me addicted to carbs, especially sugars, as I now binge eat, which is something I never did before. I know that Seroquel is the culprit! I suspect that Seroquel raised my sugar levels, which in turn my body spiked insulin levels and the deficit created caused this "Seroquel Hunger" to eat sugary foods to close that gap but sugar levels spiked again and so did the insulin and thus the viscious cycle continues. I gotta get off this stuff! And I want my body back! Why was I put on an anti-psychotic for depression anyway?! Now that I am obese I am even more unhappy. Sigh.

  • CassandraDecember 20, 2010 at 8:00 am

    I am 20 years old and I was on Seroquel for 3.5 years. It has made my life a living hell. I was told I was being put on Seroquel for depression. I was put on 200 mg and was taking it for 3.5 years. I now have diabetes and hypothyroidism and I am now 335 pounds. I use to weight 220 pounds. I have refuse to take this drug any longer. I am now on a detox program with minimal to little withdrawel symp[Show More]I am 20 years old and I was on Seroquel for 3.5 years. It has made my life a living hell. I was told I was being put on Seroquel for depression. I was put on 200 mg and was taking it for 3.5 years. I now have diabetes and hypothyroidism and I am now 335 pounds. I use to weight 220 pounds. I have refuse to take this drug any longer. I am now on a detox program with minimal to little withdrawel symptoms. Had i been properly informed about the side effects of this drug and the NASTY NASTY NASTY withdrawel symptoms i would have never put this drug in my body. Some of the withdrawel symptoms I have are insomnia, headache, vommiting, nausea, itching, a red rash all over my body, metallic taste in mouth, uncontrollabe crying, muscle spasm and swollen joints and pain. This is my second attempt to get off this medication. The first time the withdrawel symptoms were so horrific I had to call and ask my doctor for samples severl times because I could no longer afford the medication for financial reasons as well as health reasons. This drug is controlling and you almost feel like a drug addict taking it. This stuff shiuld be taken off the market and the Astrazeneca company needs to take responsibility for ruining so many lives with this crap. When you go to your doctor you expect your doctor to precsribe the right medications and treatments for you, well how can he or dhe do that if they are improperly informed about the treatment as well. I have been off seroquel for 7 days and I am refusing to ever take this crap again.

  • LonnyAugust 25, 2010 at 9:26 am

    About ten years ago a great deal of stess in my life came to be I am only 36 yers old now so this all happened when I was about 25 to 26 years old. I was placed on Seroquel 50 mgs and it was slowley increased all the way up to 300 mgs all for a sleep disorder. Since then I gained about 150 pounds and have had more problems added like sleep apnia and the ultimate a heart attack which occured about [Show More]About ten years ago a great deal of stess in my life came to be I am only 36 yers old now so this all happened when I was about 25 to 26 years old. I was placed on Seroquel 50 mgs and it was slowley increased all the way up to 300 mgs all for a sleep disorder. Since then I gained about 150 pounds and have had more problems added like sleep apnia and the ultimate a heart attack which occured about four years ago that resulted in a stent being placed in the upper region of my heart. Needless to say I have since switched medication to something a little less damageing, but too late the damage has been done now living with the facts of taking tons of medication and sleeping with a sleep apnis machine everynight. I do have all the records and information one would need.

  • AliciaMay 19, 2010 at 4:56 pm

    I have been on Seroquel since I was seventeen years old! I have gained excessive amount of weight. I have also here recently been diagnosed with high blood pressure, and I am being tested for diabetes. It was prescribed for bipolar, and sleep, but it has one nothing but make my life hell! I am 21 years old, and have high blood pressure, and possibly diabetes!

  • peggyMay 5, 2010 at 3:45 am

    ive been an seroquel for almost two years now and it has basicaly made my life hell.......i was told it was for my insomnia and for depression....today on May 4th have been diagnosed with high blood pressure......accessive weight gain 70lbs and diabetes.......very difficult to to day by day tasks or hold a job.....I am a single mother of four and think they should pull this drug in its compleatly [Show More]ive been an seroquel for almost two years now and it has basicaly made my life hell.......i was told it was for my insomnia and for depression....today on May 4th have been diagnosed with high blood pressure......accessive weight gain 70lbs and diabetes.......very difficult to to day by day tasks or hold a job.....I am a single mother of four and think they should pull this drug in its compleatly and take responsibility for what they have done to thousands of people

  • andozorkOctober 20, 2009 at 9:53 am

    The key to Astrazenecas culpability evolves around al ittle known fact Doctors are allowed to prescribe medicine for any use outside of FDA approved uses- IOW's new uses can be had with old drugs. Doctor's typically are not resreach orientated as we all know rely on drug compnay sales reps for these things people with bi polar and mood disorders for the most part stop taking their meds when the[Show More]The key to Astrazenecas culpability evolves around al ittle known fact Doctors are allowed to prescribe medicine for any use outside of FDA approved uses- IOW's new uses can be had with old drugs. Doctor's typically are not resreach orientated as we all know rely on drug compnay sales reps for these things people with bi polar and mood disorders for the most part stop taking their meds when they feel good thus causing their next ebsuing episode to rachet up so high they end up in a hospital well one shot of seroquel knocks them out. Insurance being what it is hospital vistits are to be avoided is why this nasty pill is such in demand by all medical professionals. they are hiding the fact from us who do take as scheduled and not are dying slowly from tryingto follow an incidious game that kills those who try to help themselves and rewards the ones who refuse. when thinsg get out of hand they go for a hit same as street drug more deadlier.

  • DanielAugust 25, 2009 at 6:07 am

    I was prescribed seroquel for insomnia and am amazed that it was prescribed at all for that purpose, as it had me tied up in knots and very anxiety ridden after taking just 25 mg/day for two weeks. This was prescribed with Bupropion - which is seriously contraindicated as having the ominous results interacting together. Though my doctor was aware of it's tartative disconitia capability, he neverth[Show More]I was prescribed seroquel for insomnia and am amazed that it was prescribed at all for that purpose, as it had me tied up in knots and very anxiety ridden after taking just 25 mg/day for two weeks. This was prescribed with Bupropion - which is seriously contraindicated as having the ominous results interacting together. Though my doctor was aware of it's tartative disconitia capability, he nevertheless went ahead and tried to prescribe the medication at 100 mg a day on top of the Bupropion.

  • WilliamAugust 7, 2009 at 5:22 am

    I was prescribed Quetiapine, which is also known as Seroquel, at the Denver VA, but was never told why it was actually being prescribed. Physicians fell below the "Standard of Care." The DSM lV is a book of symptoms not supported by testing. I will stand to defend veterans who serve this country. There should never be a conflict of interest among physicians, while ignoring patient safety. Get a co[Show More]I was prescribed Quetiapine, which is also known as Seroquel, at the Denver VA, but was never told why it was actually being prescribed. Physicians fell below the "Standard of Care." The DSM lV is a book of symptoms not supported by testing. I will stand to defend veterans who serve this country. There should never be a conflict of interest among physicians, while ignoring patient safety. Get a copy of your medical records, and question what is in your records, with a patient advocate. "Informed Consent," requires a physician to inform of diagnosis, which I was never informed. Say "Yes" to testing and "No" to guessing !

  • DainaJuly 27, 2009 at 1:45 am

    I took Seroquel for about 3 months for insomnia and gained 55 lbs. It caused sleep apnea which I can't kick & cant treat due to my low income and no health insurance. I never snored the way I do now and it is affecting my relationship, self-esteem, amount of energy and happiness. Im woken up at least 2-3 times a night being told to roll over because im snoring loud. Ive only been able to drop 15 l[Show More]I took Seroquel for about 3 months for insomnia and gained 55 lbs. It caused sleep apnea which I can't kick & cant treat due to my low income and no health insurance. I never snored the way I do now and it is affecting my relationship, self-esteem, amount of energy and happiness. Im woken up at least 2-3 times a night being told to roll over because im snoring loud. Ive only been able to drop 15 lbs since stoppling Seroquesl even though its been about 2 years. jogging, weights, and crunches doesnt matter. Im 5'2' and overweight at 150kbs. Its just too much to handle. I dont believe Im getting the care I need. I need someone to take responsibility for prescribing a drug that made my Bi-Polar, depression, and anxiety worse. its been since 2003 and no improvement. Its time for some answers. Im afraid i have diabetes or something but cant afford to go to the doctor. Literally have $2 in my account.

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