Quetiapine fumarate—sold under the brand names Seroquel, Seroquel XR (extended release), and Ketipinor —is among the atypical (second generation) antipsychotic medications that the FDA has determined put dementia patients at an increased risk of death compared to placebo. In trials, the causes of death were varied, but most of them appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
If you or a loved one has taken Seroquel and you believe it caused cardiovascular disease, pneumonia, or some other negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group, knows this, and we want you to believe it. We might be the Seroquel law firm you are looking for.
What Is Seroquel and What Is Prescribed For?
Seroquel is the brand name for the drug quetiapine fumarate. Made and sold by British pharmaceutical company AstraZeneca, this prescription medication is used to treat schizophrenia in adults and adolescents aged 13-17 and Bipolar I Disorder in children and adults aged 10 and up. Doctors often prescribe it in conjunction with lithium or divalproex.
The U.S. Food and Drug Administration (FDA) first approved Seroquel for schizophrenia in September 1997. AstraZeneca’s U.S. quetiapine patent expired in 2011, but it received a one-year pediatric exclusivity extension until March 26, 2012. Drug-makers sell quetiapine in 25 mg to 400 mg oral tablets. AstraZeneca received $5.3 billion in Seroquel sales in 2010 worldwide, of which $3.7 billion came from the United States.
According to the drug’s label, scientists do not understand Seroquel’s mechanism of action, though that is not uncommon for drugs indicated for treating schizophrenia. Medical experts speculate that Seroquel blocks dopamine Type 2 receptors and serotonin Type 2 receptors in the brain. It’s less likely than some antipsychotic drugs to cause involuntary body movements at low doses.
AstraZeneca has settled multiple Seroquel-related lawsuits against the United States and state governments. In April 2010, for $520 million, AstraZeneca settled a lawsuit brought by the U.S. Department of Justice for illegally marketing Seroquel for off-label uses while failing to mention Seroquel’s side effects. In March 2011, 37 U.S. states settled their own claims against AstraZeneca for $68.5 million.
Seroquel Might Cause Life-Threatening Side Effects
When Prescribed for Dementia in the Elderly, Seroquel Might Cause Deadly Strokes
The FDA does not approve Seroquel for the treatment of dementia in the elderly, and it requires a black box warning on the product’s label informing users that the drug carries an increased risk of death in elderly users. The FDA has determined that elderly people with dementia who used atypical (second generation) antipsychotic medications including Seroquel were 1.6-to-1.7 times more likely to die of various ailments, including heart disease and pneumonia.
According Seroquel’s FDA-approved product labeling, a potentially fatal disorder sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Seroquel. Symptoms of NMS include:
- Muscle rigidity;
- Altered mental status; and
- Autonomic instability (irregular heartbeat or blood pressure, excessive sweating).
Seroquel’s labeling also states that a potentially irreversible condition known as Tardive Dyskinesia has been associated with Seroquel use. Tardive Dyskinesia is characterized by involuntary facial movements such as:
- Puckering and pursing of the lips;
- Tongue protrusion;
- Lip smacking; and
- Rapid eye blinking.
Seroquel Might Cause Behavioral Side Effects
Seroquel carries a “black box” (i.e., serious) suicide warning for adolescent and young adult users. The FDA found that young people who used Seroquel to treat major depressive disorder were more prone to suicidal thoughts and behaviors than depressed adolescents and young adults who took a placebo. Researchers calculated that for every thousand users who were less than 18 years old, Seroquel was responsible for 14 additional cases of suicidal ideation and behavior. For every thousand users between the ages of 18 and 24, Seroquel was responsible for five additional cases of suicidal ideation and behavior.
Seroquel Might Cause Hyperglycemia and Diabetes
The FDA requires Seroquel’s drug label to include hyperglycemia and diabetes mellitus warnings in its “Warnings and Precautions” section. In one placebo-controlled trial, the percentage of adult users whose fasting glucose shifted from less than 100 mg/dL to greater than 126 mg/dL increased nearly twofold in the Seroquel group over the placebo group. Due to this Seroquel side effect, close to 30,000 users filed Seroquel diabetes lawsuits against AstraZeneca. The manufacturer settled 17,500 of the lawsuits in August 2010 for $200 million and in February 2011, it settled another 6,000 lawsuits for $150 million. Some Seroquel diabetes lawsuits are still pending in state court.
Seroquel Might Negatively Affect Your Heart
In July 2011, the FDA announced a Seroquel label revision concerning heart-related side effects. According to a New York Times article, 17 people reported to the FDA that they experienced arrhythmia (abnormal electrical activity of the heart) after taking more than the recommended doses of Seroquel. The revised label lists 12 drugs that doctors should avoid prescribing to patients taking Seroquel: Quinidine, Procainamide, Amiodarone, Sotalol, Ziprasidone, Chlorpromazine, Thioridazine, Gatifloxacin, Moxifloxacin, Pentamidine, Levomethadyl Acetate, and Methadone.
Seroquel Might Cause Pregnancy Side Effects
Since February 2011, the “Pregnancy” section of Seroquel’s label has informed doctors and women who are about to become pregnant that, when a woman takes Seroquel during pregnancy, it can cause withdrawal symptoms in infants in the form of abnormal muscle movements (called extrapyramidal signs (EPS)).
Symptoms of EPS include:
- Hypertonia (excessive muscle rigidity);
- Hypotonia (excessive muscle elasticity);
- Somnolence (sleep disturbances);
- Respiratory distress; and
- Feeding disorder.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group do everything they can to streamline the process, and they will file a Seroquel lawsuit on your behalf if necessary.
If you believe you have experienced adverse side effects as a result of taking Seroquel, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Seroquel lawsuit.