Settlement Over Seroquel Reached for $520M with Dept. of Justice: Report
AstraZeneca has agreed to pay the U.S. government $520 million to settle charges over Seroquel, resolving a federal probe that accused the drug maker of illegally promoting their popular antipsychotic medication for non-approved uses.
The settlement over Seroquel is expected to be announced Wednesday by the U.S. Department of Justice (DOJ), according to a report by the New York Times. AstraZeneca will not admit to wrongdoing in the settlement, and will enter into a corporate integrity agreement with DOJ.
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 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.
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While doctors are free to prescribe approved medications for non-approved uses, drug makers are barred from promoting or encouraging such “off-label” use. Since it was approved, Seroquel has been used by more than 19 million people worldwide, and some people have estimated that at one time as much as 70% of all seroquel prescriptions were for unapproved uses.
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 over 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.
The company first announced it had reached an agreement in principle to settle the Seroquel case with the DOJ in a November filing with the U.S. Security Exchange Commission (SEC).
In addition to the federal probe, AstraZeneca faces an estimated 26,000 Seroquel lawsuits in state and federal courts throughout the United States involving allegations that the drug maker failed to adequately warn about the risk of serious side effects. In November 2009, a federal judge presiding over thousands of cases ordered both sides to meet with a mediator to see if there is any possibility for a settlement of Seroquel injury cases before individual trial dates are scheduled in federal district courts throughout the United States.
noreenFebruary 21, 2014 at 9:36 pm
On January 9th, 2014 was the worst day of my life! As I type this my heart is pounding and my legs are shaking. In the beginning of January I was not feeling well and went to my doctor on the 6th of January. I was diagnosed with a low grade fever and gastroentits. On the 8th of January I still was not feeling well, but was a little better. That night I just wanted to get a good nights sleep a[Show More]On January 9th, 2014 was the worst day of my life! As I type this my heart is pounding and my legs are shaking. In the beginning of January I was not feeling well and went to my doctor on the 6th of January. I was diagnosed with a low grade fever and gastroentits. On the 8th of January I still was not feeling well, but was a little better. That night I just wanted to get a good nights sleep as I had to get up at 6:30 a.m. to see my daughter off to school;; also I had a psychiatrist appointment on the 9th of January. I thought to myself maybe if I get a good nights sleep I may be able to go to my appointment which is about 50 minutes from where I live. My doctor had recently increased my Seroquel to 300mg from 150mg. I was having severe anxiety. I also was going to cancel my appointment in the morning if I still didn't feel well. The 8th of January is the last day I remembered until the 10th of January. On the morning of the 9th the only thing I remember was my daughter saying "mommy you have to get up you never sleep thru your alarm. I never heard the alarm nor do I remember getting out of bed. I nearly lost my life or maybe had killed someone else since I had a blackout on the 9th and it was the most frightening thing that has ever happened to me. Since I was unconscience yet awake at the same time and drove to m doctors. Also, nearly overdosed on my other prescribed meds bebcause of what the Seroquel had done to me. Everyone had to fill me In on everything that happened on that terrible day. My doctor said I was really in a bad way, exhausted and slurring my words. This is before I took any other medication that day, I had brought them with me. At some point, I took the medication which is for migraine and a herniated disc, I nearly had a nervous breakdown on the 10th of January after I counted my meds and could not believe what I had done. I had them in a aspirin bottle and the only thing that I could try to figure out is that I thought they were aspirin; I have never taken medication with me anywhere before, nor would I put them in a aspirin bottle. My doctor tried to get me a taxi, but since my brain or thinking was totally gone I thought I was fine. I left and went to cvs pharmacy and into a dunkin donuts to get a coffee and they said I was so bad they called the police and a woman had to help me make my coffee and walk me to my car. A few minutes later I was in a car accident, I hit the back of a car, I am thanking god every day that this man was not hurt, I DO NOT remember any of this. This police officer wrote out a report and let me drive all the way back home. The front of my parents car in bad shape and why didn't this police officer notice there was anything wrong with me. As I somehow made it back to Milford,pa where I live, someone called the cops on me since I was swerving very bad. I was taken for a blood test since they couldn't figure out what was wrong with me. I was then brought back to the police station when they contacted my husband. My husband told me I slept 15 hours and when I woke up I called my parents and told them I needed their keys to go to my doctor appointment. My parents had to tell me what happened, as I checked my calendar and could not believe it was the 10th of January, I cried for hours after hearing what happened to me the day before. I am 50 years old and have never been in trouble before and would never drive a car even if I had a few sips of beer or other mind altering drugs; I have been suffering every day since then. I cannot function, eat barely and rarely sleep. I am devastated by what happened to me. I could have killed someone or myself because of what Seroquel did to me. I was never told about side effects from this drug or I would have never taken it. I can barely make it thru the day and cry every night while my heart pounds out of my chest and I shake, this I now realize is from Seroquel. I couldn't understand why I was having such bad anxiety until I started doing some research today, and I am shocked and horrified by the stories I have read and by what happened to me. I never had a chance that day since I was brain dead, to make a decision to cancel my appointment. I have been thru more emotions since that horrible day and can barely make it thru the day. I am now planning on cutting down and then off this drug, it nearly destroyed my life and in reality I am deeply suffering. I also noticed I can't even swallow an aspirin without choking, I never had this problem before. I am not bipolar or any other disorder except I had a sleeping problem. What this drug nearly did to me and what now I am going thru I am planning to sue. This is a deadly drug, and should not be given to anyone. I know people have issues, but take anything but Seroquel and always get information on what you are taking or your life or others are in jeopardy. Please excuse any typos as I am shaking again today and know that there is now another nightmare path I have to take to get off of Seroquel. I truly hope I can help other people out there who are taking this drug, please get off of it, but do not go cold turkey; you can become very sick. I also did not know this. god blesss
wesleyApril 29, 2010 at 8:52 pm
i take seroquel several times a day. when i was off it for a short period of time and had started back on the seroquel, i had a blackout period time that i could not remember. my ex girlfriend told me i was going off the wall and going nuts. i wish i could remember what happened. i lost her, at which i was with her for 4 years. she still don`t want to talk about it. this screwed up my life.
kassieApril 27, 2010 at 10:22 pm
I was prescribed seroquil for bipolar disorder while I was hospitalized last year. The only side effect that I was told about was the affect of causing drowsiness and potential weight gain. I was not informed of any other side effects. I began shaking a lot when I didnt' take it, which I guess meant that I was addicted to it and was not told of that possiblility of it either. To this day, eve[Show More]I was prescribed seroquil for bipolar disorder while I was hospitalized last year. The only side effect that I was told about was the affect of causing drowsiness and potential weight gain. I was not informed of any other side effects. I began shaking a lot when I didnt' take it, which I guess meant that I was addicted to it and was not told of that possiblility of it either. To this day, even though I am off of it, I still do not know of the entire list of side effects of the medication.
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