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]

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Seroquel-wiki.jpg
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
 
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Contents

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]
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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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Also See: Seroquel Coupons, Seroquel Free Samples, Seroquel Side Effects, Abilify, Abilify Side Effects, Aripiprazole Side Effects, Depakote, Depakote Side Effects, Geodon Side Effects, Lamictal Side Effects, Lithium, Paxil Side Effects, Risperdal Side Effects, Zyprexa Side Effects

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References

  1. 1.0 1.1 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001030/
  2. 2.0 2.1 http://www.justice.gov/opa/pr/2010/April/10-civ-487.html
  3. http://www.genengnews.com/gen-news-highlights/astrazeneca-to-pay-520m-settlement-in-seroquel-lawsuit/78565333/
  4. 4.0 4.1 4.2 http://www.nytimes.com/2009/02/28/business/28drug.html
  5. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/04/dc-circuit-rules-for-fda-in-seroquel-exclusivity-case-astrazeneca-not-entitled-to-3-year-exclusivity.html
  6. 6.0 6.1 6.2 6.3 6.4 6.5 http://www1.astrazeneca-us.com/pi/Seroquel.pdf
  7. 7.0 7.1 http://google2.fda.gov/search?q=seroquel&proxystylesheet=FDAgov&site=FDAgov-Recalls-Safety