Seroquel Lawsuit

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Seroquel® (quetiapine) is a prescription antipsychotic medication, approved by the FDA to treat the symptoms of schizophrenia and bipolar disorder. Seroquel® carries a black box warning (the FDA's strongest advisory) for increased mortality among elderly patients with dementia-related psychosis. Therefore, this drug is not approved for elderly dementia sufferers.[1]

Manufacturer AstraZeneca denies marketing Seroquel® to doctors for off-label uses like dementia-related psychosis; however, they have reached settlements with the Departments of Justice and Health and Human Services and with 37 states and the District of Columbia to resolve allegations of illegal marketing.[2] [3] AstraZeneca also faces thousands of personal-injury lawsuits from former users of Seroquel®.[4]

In March of 2012, AstraZenica filed a lawsuit against the FDA in an attempt to block the marketing of generic versions of Seroquel®. A district court ruled for the FDA in April 2013, supporting a lower court's prior ruling.[5]


Wikimedia: Luke-2
Brand name for Quetiapine[6]
Manufacturer AstraZeneca[6]
Prescribed for Schizophrenia and bipolar disorder[6]
Complications Neuroleptic malignant syndrome, diabetes, weight gain, tardive dyskinesia, death[6]
Warnings Increased mortality in elderly patients with dementia-related psychosis; increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders.[6]
Recall Date None[7]
Class action lawsuit filed Yes
Disclaimer The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Selena Robinson


Seroquel Side Effects

Seroquel® may cause several side effects, some of which may be serious or may require medical attention. Common adverse reactions of Seroquel® may include:

  • Drowsiness
  • Dizziness
  • Headache
  • Irritability
  • Difficulty thinking or concentrating, difficulty speaking or using language, unusual dreams
  • Loss of coordination
  • Pain in the joints, back, neck, or ears
  • Numbness, burning, or tingling in the arms or legs
  • Indigestion, gas, or stomach pain or swelling
  • Constipation
  • Increased appetite or excessive weight gain
  • Missed menstrual periods
  • Discharge from the breasts, males may experience breast enlargement
  • Decreased sexual desire or ability

Serious side effects of Seroquel®, which may require medical attention, include:

  • Fainting or seizures, changes in vision
  • Uncontrollable movements of arms, legs, tongue, face, or lips
  • Tongue sticking out
  • Difficulty breathing or swallowing
  • Fever, sore throat, chills, difficult or painful urination and other signs of infection
  • Muscle stiffness, pain, or weakness
  • Priapism (painful erection of the penis that lasts for hours)
  • Fast or irregular heartbeat
  • Unusual bleeding or bruising
  • Confusion
  • Extreme thirst, frequent urination, extreme hunger
  • New or worsening depression, suicidal thoughts or plans, extreme worry, panic attacks, difficulty falling asleep or staying asleep, aggressive behavior, acting without thinking, severe restlessness, and frenzied abnormal excitement[1]

Seroquel Warnings and Recalls

AstraZeneca warns of these and other potential adverse effects as a result of using Seroquel®:

  • Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
  • Suicide: Patients may experience worsening of their depression and/or the emergence of suicidal ideation and behavior.
  • Neuroleptic Malignant Syndrome (NMS): Potentially fatal; symptoms may include high fever, sweating, unstable blood pressure, stupor, muscular rigidity, and autonomic dysfunction.
  • Hyperglycemia and diabetes mellitus, weight gain
  • Hyperlipidemia (high blood cholesterol levels)
  • Tardive dyskinesia: potentially irreversible condition; symptoms include involuntary, repetitive movements, which may arise after discontinuation of treatment.
  • Orthostatic hypotension (low blood pressure), QT prolongation, increases in blood pressure in children and adolescents: Seroquel® should be used with particular caution in patients with known cardiovascular disease.
  • Leukopenia, neutropenia and agranulocytosis (loss of white blood cells): agranulocytosis is potentially fatal.
  • Cataracts: observed in animal studies.
  • Seizures: Seroquel® should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer’s dementia.
  • Hypothyroidism (low thyroid hormone levels)
  • Hyperprolactinemia: increase of the prolactin hormone in the blood. May cause discharge from the breasts, males may experience breast enlargement.
  • Transaminase Elevations: Elevation of liver enzymes, may indicate liver damage.
  • Potential for Cognitive and Motor Impairment: Several patients reported somnolence (severe need for sleep), especially when starting Seroquel®.
  • Priapism (painful erection of the penis that lasts for hours)
  • Dysphagia (difficulty swallowing)[6]

Seroquel® has not been recalled.[7]

Seroquel Class Action Lawsuits

Thousands of patients who have formerly used Seroquel® have filed individual and class action lawsuits against AstraZeneca. These patients claim to have suffered various side effects of Seroquel®, most notably diabetes. Other patients claim to have suffered harm from off-label use of Seroquel® to treat conditions such as depression, insomnia, attention deficit disorder and dementia.[4]

AstraZenica reportedly hid information about the negative side effects of Seroquel®, as documented by internal correspondence. Investigators uncovered an e-mail from company higher-up Richard Lawrence, regarding Seroquel® project physician Lisa Arventis, that read “Lisa has done a great ‘smoke-and-mirrors job!’" The job in reference was her glossing over the dangers of the drug, which were discovered in a study that Lawrence described as "cursed" in the same e-mail. This e-mail, along with other documents, helped to prove that AstraZenica had known that Seroquel® caused diabetes and weight gain for almost ten years, but covered up the facts from physicians as well as the general public.[4]

Seroquel Lawsuit Settlements

On April 27, 2010, AstraZeneca agreed to pay a total of $520 million to resolve allegations that AstraZeneca illegally marketed Seroquel® for off-label uses. AstraZeneca agreed to pay the federal government approximately $302 million, and approximately $218 million to 37 U.S. states and the District of Columbia. AstraZeneca has admitted no wrongdoing.

From the settlement, AstraZenica was ordered to pay $301,907,007 to the federal government, and $218,092,993 to be distributed to state and District of Columbia Medicaid programs.[2]

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