Settlement Over Seroquel Off-Label Reached by AstraZeneca With States
AstraZeneca has reached a $68.5 million settlement over Seroquel with 37 states for claims that involve allegations the drug maker illegally marketed the atypical antipsychotic for off-label uses, and hid the potential risk of Seroquel side effects like weight gain and diabetes.
The Seroquel settlement was announced last week and addressed a number of charges. AstraZeneca has agreed to meet state and federal marketing standards for Seroquel and to publish payments it makes to physicians on the internet for public knowledge. The agreement also will require the company to make new policies that will restrict sales representatives from marketing the drug to health care providers who are likely to prescribe it for off-label purposes.
Federal regulations prohibit drug companies from marketing drugs for purposes not approved by the FDA. However doctors are allowed to prescribe drugs for any purpose that they believe will improve the health of their patients.
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Learn MoreThis latest agreement follows thousands of individual settlements over Seroquel reached over the past year with individuals who developed diabetes or other serious injuries as a result of the medication.
Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has also been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism.
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 Seroquel lawsuits filed by consumers who developed diabetes and other health problems after using the drugs, internal company papers were uncovered 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.
AstraZeneca reached a $520 million settlement with the Department of Justice (DOJ) over off-labeling charges last year.
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13 Comments
rickeyMarch 11, 2012 at 12:23 am
im on seroqule 200 xr i notes i have camre adiebeck i have cande weat i have never ben a diebacke it does not run in r frlme till i got on seroqule whant can i do
CynthiaSeptember 17, 2011 at 10:08 am
I was given Seroquel to treat bipolar disorder. I ended up with a drawn-out case of Neuroleptic Malignant Syndrome. Had a few hospital stays, the 2x I was in ICU came to $29,000. That's not counting the many other hospital ER visits with high fevers, comatose, lead-pipe. Thankfully I don't remember much - my husband said I screamed in pain whenever anyone touched me. I've got brain damage, can't r[Show More]I was given Seroquel to treat bipolar disorder. I ended up with a drawn-out case of Neuroleptic Malignant Syndrome. Had a few hospital stays, the 2x I was in ICU came to $29,000. That's not counting the many other hospital ER visits with high fevers, comatose, lead-pipe. Thankfully I don't remember much - my husband said I screamed in pain whenever anyone touched me. I've got brain damage, can't regulate my body temp. Can't go out in sun, my skin starts to peel & my temp goes up. Bad short-term memory. My heartrate went up to over 172, they had to stop my heart with drugs 3 times to slow it down.
LindaJuly 12, 2011 at 12:03 am
What did this extreme drug contribute to my ultimate health? Let me evaluate it first after gaining 100 pounds in a matter of months my self worth became invisiible to myself and others After being a size four even after my three children grew up it was incorruptible foreiign and now manufacture dreams have come into play. My God given right to be happy no matter what my status or zip code was [Show More]What did this extreme drug contribute to my ultimate health? Let me evaluate it first after gaining 100 pounds in a matter of months my self worth became invisiible to myself and others After being a size four even after my three children grew up it was incorruptible foreiign and now manufacture dreams have come into play. My God given right to be happy no matter what my status or zip code was remove from me and held me hostage. I was in the medical field for years but after ingesting 700mg seven days a week for years and i was taught if you're ill you seek help. What a tremendous let down to develop such a continual chronic severe undeserve critical unstable disease. Stayed in the house for five years only went out to the Doctor's office and grocery store my life as i new it was over. To sum it all up Father Knows Best days are over humanity has been depense with prominent preserve statue lover's of money rather man or woman even children. I'm no longer viable as far as my health but i'm visible because i'm a fighter i lost on my own 100lbs. I still live with this difficult disease and with my dignity!!!!!!!!!!
MelvaJuly 6, 2011 at 3:04 am
I have a question about the settlement and my personal share . Please commet to give realitive ansewer
carolynJune 22, 2011 at 3:47 pm
how long on the settlement to be freed to the clients and what the percent of each person, and what the fees and other legal fees that may come up. i have two cases on filed with my lawyers and one in another case to i want to know what the out come and how much each one pays to me.
KarenJune 21, 2011 at 6:08 pm
I weighed 125 when I started taking seroquel and after only one year I gained 100 pounds. I only took it at night but developed leg jerks, so I had to take another drug for that. I deverloped diaetes and had kidney failure because of that. I always felt drowsy and could not function. I have lost 70 pounds now and diet control the diabetes. My kidneys still not completely right. This is a ve[Show More]I weighed 125 when I started taking seroquel and after only one year I gained 100 pounds. I only took it at night but developed leg jerks, so I had to take another drug for that. I deverloped diaetes and had kidney failure because of that. I always felt drowsy and could not function. I have lost 70 pounds now and diet control the diabetes. My kidneys still not completely right. This is a very dangerous drug and should only be prescribed as a last resort for antiphsycotic reasons!!!!
CharmaineJune 8, 2011 at 7:12 pm
My mom was on Seroquel for years and was diagnosed with diabetes. Diabetes does not run in my family at all. We have been waiting a few years for this lawsuit to go through. I'll be glad when they finish so that my mom can pay her medical bills. I also want to say that you all should very careful with antidepressants and psyche meds, because they all have very unhealthy side effects and they are n[Show More]My mom was on Seroquel for years and was diagnosed with diabetes. Diabetes does not run in my family at all. We have been waiting a few years for this lawsuit to go through. I'll be glad when they finish so that my mom can pay her medical bills. I also want to say that you all should very careful with antidepressants and psyche meds, because they all have very unhealthy side effects and they are not worth losing your precious lives over. Be encouraged. And trust God to bring you through. I used to suffer from depression and suicidal tendencies, but when I put my hope and faith in the greater power than myself, then my spirit and mind was set free. Once and for all. Jesus has your perscription with no side effects=)
pamelaJune 3, 2011 at 3:31 am
i was on this med along time i went from 135 pounds up to 250 n less then a year it gave me diabetese n chronic pancriatic changes i am on the newest meds for type 2 diab if it doesnt control it i will have to become insulin dependent i pray for u all god bless and im only 41 years old
JohnJune 1, 2011 at 12:32 pm
Just to let everyone know who is in the Litigation. I recieved a letter the other day and we Won finaly ! Their goig to be doing Individual Claims and some kind of Master General will determine what you should get instead of a Grid Payment. Not saying thats any better but I think it is. Because I have had some serious problems from taking Astra's Drug. But we all have. I'm just happy its coming to[Show More]Just to let everyone know who is in the Litigation. I recieved a letter the other day and we Won finaly ! Their goig to be doing Individual Claims and some kind of Master General will determine what you should get instead of a Grid Payment. Not saying thats any better but I think it is. Because I have had some serious problems from taking Astra's Drug. But we all have. I'm just happy its coming to an end.
TerryMarch 31, 2011 at 4:05 pm
I have been on Seroquel since 2004 I have since gained over 100 pounds and now have High blood pressure and extreme bad head aches. After taking 100- 150 mg every day. I experience constant movement with my legs that I move back and forth First time I heard about this lawsuit. I am wondering if it is too late to talk to a lawyer.
tracyMarch 26, 2011 at 4:51 pm
My Dr. also put me on Seroquel this past August and within 3 months I had put on 40+ lbs. and major water retention. I was unable to walk 10 feet without having to sit down from the excruciating pain in my lower back. It was hard just maintaining personal hygiene, getting dressed and breathing became labored with the smallest tasks. As a result of my inability to even walk properly I lost balance [Show More]My Dr. also put me on Seroquel this past August and within 3 months I had put on 40+ lbs. and major water retention. I was unable to walk 10 feet without having to sit down from the excruciating pain in my lower back. It was hard just maintaining personal hygiene, getting dressed and breathing became labored with the smallest tasks. As a result of my inability to even walk properly I lost balance and fell face first receiving cuts on my face with permanent scarring and a concussion! This was my third fall. I refused to take the medication and am now off since Dec. but I still have chest pains and breathing problems along with muscle / joint pain. I feel poisoned :(
BeckyMarch 16, 2011 at 12:17 pm
In 2007, my VA doctor put me on Seroquel for my anxiety and sleep needs. I was on it for 3 months before I told him to change it. Within that 3 month period, I gained 40 pounds. It took me 2 years to shed that unhealthy weight.
sammyMarch 14, 2011 at 10:46 pm
I was given Seroquel scripts every month for four years. I have diabetes. I just got out of the hospital with a pace maker being placed in my chest. I slept all the time not knowing day from nite.