Seroquel (quetiapine fumarate) is an atypical antipsychotic medication. Clinicians prescribe this drug to patients with:
- Bipolar disorder
- Major depressive disorder
- Bipolar depression
The FDA approved this drug for the short-term treatment of patients suffering from manic episodes.
Seroquel is effective at treating patients with extreme cases of schizophrenia and bipolar disorder. But the drug has severe side effects. Studies show that younger patients who take this drug have an increased risk of suicidal thoughts. Studies have also shown an increased risk of death in dementia patients who take this medication.
Here, we'll highlight some recent news and research on Seroquel and Seroquel XR. We'll also explain what to do if you or your loved one becomes sick after using this drug.
Studies Confirm Severe Side Effects of Seroquel
Many patients have reported adverse side effects of taking Seroquel and Seroquel Extended-Release. Clinical trials confirm these adverse health consequences.
Severe side effects of Seroquel include the following:
- Parkinson's disease
- Kidney problems
- Problems with the central nervous system (CNS)
- Tardive Dyskinesia
- Low blood pressure
- Liver problems
- Irregular heartbeat
- Serotonin syndrome
- Neuroleptic malignant syndrome (NMS)
Patients have reported experiencing dangerous levels of sedation within hours of taking this atypical antipsychotic drug.
Nov. 16, 2006: FDA Issues Warning on Misleading Seroquel Material
In November 2006, the U.S. Food and Drug Administration (FDA) sent a letter to AstraZeneca. The FDA demanded that it immediately stop disseminating false and misleading promotional materials about Seroquel.
According to the FDA, the materials minimized Seroquel patients' risk of developing hyperglycemia and diabetes. The agency also said the materials omitted important information about other potentially dangerous side effects of the drug.
April 2006: FDA Alert — Seroquel Use in Older Patients
In April 2006, the FDA issued an alert that older patients taking atypical antipsychotics (such as Seroquel) for dementia had a higher chance of death. This higher incidence of death was in comparison with patients who did not take the drug.
The FDA further stated that it did not approve the use of atypical antipsychotics to treat dementia. The FDA asked the pharmaceutical industry manufacturers to change their labels to include this warning.
November 2010: Department of Justice Fines AstraZeneca $520M for Off-Label Marketing
In 2010, the United States Department of Justice charged AstraZeneca with unlawful promotion of Seroquel for off-label uses. The drugmaker was marketing the drug to health care providers for uses other than the treatment of schizophrenia and bipolar disorder.
The allegations included charges that the drug manufacturer was promoting Seroquel for the following:
- Sleep disorders
- Aggression and hostility
- High cholesterol
- Dementia-related psychosis
- Attention Deficit Hyperactivity Disorder (ADHD)
- Mood disorders
- Anger management
AstraZeneca vehemently denied the allegation. But, it agreed to pay the $520 million fine.
March 2011: State of Washington Sues AstraZeneca for Improper Marketing
After a three-year investigation, the Attorney General for the State of Washington filed a settlement and complaint against AstraZeneca for improper marketing of Seroquel. The drugmaker gave prescribing physicians and health care providers misleading information about the antipsychotic medication.
The Attorney General claimed that the drug company promoted Seroquel for off-label uses. Specifically, the prosecutor argued that the pharmaceutical company said the drug was safe for children and older adults. But the FDA did not approve the drug for these populations. The FDA has already required the drug company to update its labels to include warnings about these patient groups.
The claims also alleged that AstraZeneca withheld information about the prescription drug's risks and adverse side effects.
October 2019: AstraZeneca Sells the Rights to Market Seroquel to Cheplapharm
In October 2019, AstraZeneca agreed to sell the rights to market Seroquel in Russia and Europe to Cheplapharm, a German pharmaceutical company. The patent on the drug had expired, and the drug manufacturer wanted to shift its focus to other therapy medications.
In December 2019, the drugmaker transferred the rights to sell Seroquel and Seroquel XR in the United States and Canada to the same pharmaceutical company.
August 2021: Study Confirms Seroquel Could Cause Serotonin Syndrome
In August 2021, a study found that Seroquel (quetiapine) may cause serotonin syndrome. The study reported that an 85-year-old woman went to the emergency room suffering from symptoms of serotonin syndrome.
The emergency room doctors said the woman was taking other medications along with Seroquel. The study found that large doses of Seroquel could cause serotonin syndrome.
What to Do if You Become Sick After Taking Seroquel
If you or your loved one become sick after taking Seroquel or any other prescription medication, you have options. First, seek immediate medical care. Once you get the treatment you need, contact an experienced product liability attorney.
Depending on the facts of your case, you may need to file a product liability lawsuit against the drug manufacturer. For example, if the drug company fails to disclose serious side effects of a particular medication, it may be liable for damages. The same is true if they market a drug for unapproved, off-label use. Talk to a product liability lawyer near you.
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Contact a qualified product liability attorney to make sure your rights are protected.