FDA Requests Additional Information about Expanded Seroquel Use
AstraZeneca released a statement last week indicating that the FDA has requested additional information about their antipsychotic medication Seroquel, which the drug maker is attempting to obtain expanded approval to market as a once-daily treatment of depression in adults.
Seroquel (quetiapine fumarate) was originally approved by the FDA in 1997 as a twice-daily treatment for schizophrenia, but has been widely used off-label for years for other uses.
In October 2008, Seroquel XR, extended release tablets, were approved as a once-daily treatment for mania, depressive and mixed episodes in bipolar disorder, and as maintenance treatment of bipolar disorder with lithium or divalproex.
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Learn MoreSeroquel is the second best selling drug for AstraZeneca, with annual sales of over $4 billion.
The FDA requested additional information about Seroquel XR in a Complete Response Letter, as part of their review of a supplemental new drug application filed by AstraZeneca seeking approval for use of the drug by people suffering from major depressive disorders.
The contents of the FDA communication have not been disclosed, but AstraZeneca indicates that they are reviewing the Complete Response Letter and proposed labeling revisions.
Seroquel side effects have been linked to an increased risk of weight gain, diabetes, hyperglycemia and pancreatitis, and the drug maker currently faces Seroquel lawsuits from over 13,000 people who allege they failed to previously provide adequate warnings about the risks.
The first trial in the Seroquel litigation is scheduled to begin in February 2009, and during pretrial motions earlier this month, an internal document was released which suggested that AstraZeneca was aware of the Seroquel diabetes side effects as early as 2000, yet failed to warn users of the risks for several years.
AstraZeneca indicates that they will provide a response to the FDA in due course. However, the drug maker stressed that the FDA Complete Response Letter does not change the current recommendations for individuals taking Seroquel or Seroquel XR for approved uses, such as schizophrenia or bipolar disorder.
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7 Comments
PatrickFebruary 23, 2013 at 3:01 am
I was on Seroquel from its intro to 2006 , My dosage began at 300mg and finalized at 1800mg per night all for what I suspect was a foreingn shrink and an anger problem that eventually subsided with I year with a holistic psychologist who helped me overcome my moslem shrinks hatred of the Christian Faith. I went thru 8 major surgeries during the time on Seroquel 4 pine Laminectomies with fusion and[Show More]I was on Seroquel from its intro to 2006 , My dosage began at 300mg and finalized at 1800mg per night all for what I suspect was a foreingn shrink and an anger problem that eventually subsided with I year with a holistic psychologist who helped me overcome my moslem shrinks hatred of the Christian Faith. I went thru 8 major surgeries during the time on Seroquel 4 pine Laminectomies with fusion and a skull base brain tumor leaving my face drooped and paralyzed on right side because facial nerve had to be sacrificed to remove golf ball sized tumor ,2 reconstructive surgeries and eye surgery to take a piece of the white part of lower eye and place it in the iris area to reinforce the thinning area of my eye/I am now totally disabled on no psychactive meds but see a pain specialist to address failed back surgery syndrom .Next week my neurosurgeon has ordered another ct-myelogram to determine possible cause oof excruciating lower back pain radiating to hips to kneeesmand ankles achilles tendons and feet including burning heeel pain.Please Stay away from this drug if you value you or a loved ones future
EileenDecember 9, 2011 at 9:15 pm
Marked memory loss and zero concentration. I am unemployed and unable to fill out a job application/ I am on Serquell 600 mg at night.
KimApril 27, 2010 at 8:21 pm
I've been prescribed seroquel xr for about 5 years and just learned I may have tardive dyskinesia, and was never made aware of this side effect until recently. Doctor says condition is permenant, and can only be controlled.
LisaDecember 16, 2009 at 6:39 pm
December 15, 2009 I allege that that my son, Andrew prescription for Seroquel XR 400mg 2 Tablets at 6pm daily, a medicine used for his child onset schizophrenia was improperly filled and he was given the wrong prescription. He was given Seroquel immediate-release 400mg instead. He received 800mg at night of immediate-release Seroquel for 2 weeks instead of the Seroquel XR. According to AstraZen[Show More]December 15, 2009 I allege that that my son, Andrew prescription for Seroquel XR 400mg 2 Tablets at 6pm daily, a medicine used for his child onset schizophrenia was improperly filled and he was given the wrong prescription. He was given Seroquel immediate-release 400mg instead. He received 800mg at night of immediate-release Seroquel for 2 weeks instead of the Seroquel XR. According to AstraZeneca these medicines react differently. I called the prescription shop as soon as I realized the mistake. They ( meaning pharmacist) admitted the mistake. I told him the symptoms my son was experiencing. He said that those symptoms were typical with taking the wrong Seroquel (immediate-release). During the 2 weeks he had many symptoms. He kept telling me he didn’t feel right. Complained on dizziness and nausea. He vomited in the middle of every night the first week. I couldn’t get him up in the morning. He slept in every morning. He cried with bad headaches. He wouldn’t go to school. He started eating large amounts of food and even went up 2 sizes in pants. He became irritable. The symptoms got worse. He was restless and aggressive, irrational, impulsive, and had paranoia. He thought everyone was out to get him. He had to be restrained many times. He terrorized the whole household. He would hit himself and bite himself and others. Severe panic attacks. He trashed the house several times. This happened everyday around the same time. Starting around 1pm to 2:30pm every afternoon. This would last until he finally went to sleep. The police was even called. I had Symptoms of Care (NW Behavior Health) coming to the house as a crisis. I had contacted St. Anthony’s Hospital twice inquiring about inpatient psychiatric help. All the professionals kept asking me over and over “Was I giving him his medicine”. I told them repeatedly I was. He got where he couldn’t get dressed or brush his hair without having a breakdown. He wouldn’t take a bath. He was freighted of everything. This error has caused damage to my son and everyone around him. His well-being. He may fail school due to absents during the 2 weeks. This has been very painful. I felt betrayed by the prescription shop. If I would of known about this error sooner, this wouldn’t of happened. I will be seeking damages. Lisa Mother of Andrew (Aged 12)
kcJanuary 20, 2009 at 3:34 am
p.s. i dont know of any complications so far. I am only 26 so i am scared as i took it for 3 years.
kcJanuary 20, 2009 at 3:31 am
i was prescribed seroquel to help me sleep. most other medications did not work and serquel put me out in 5 min. it was fine at first until i started to wake up in the middle of the nite and see things. i quickly got off it out of fear it was actually making me psycho. now i take ambien, have trouble sleeping but feel much better not being on it!
jillJanuary 3, 2009 at 2:30 pm
i was put on seroquel severalyears ago and withi months i blew up like a ballon. i am jist under 5 ft. tall and fluctuat between 125 and140 lbs. this deoends on how much i can push myself to excercise when i am very fatigued all the time. also i have had numerous bouts of painful pancreatitis. now i can't even have 1 alcoholic drink as that could be enogh to make me sick. now i know the reason for[Show More]i was put on seroquel severalyears ago and withi months i blew up like a ballon. i am jist under 5 ft. tall and fluctuat between 125 and140 lbs. this deoends on how much i can push myself to excercise when i am very fatigued all the time. also i have had numerous bouts of painful pancreatitis. now i can't even have 1 alcoholic drink as that could be enogh to make me sick. now i know the reason for the pancreatitis which i never had befor seroquel. because most of my weight is in my belly i'm scared becouse it;s a bad place to have it,