Seroquel is a member of a category of drugs called "psychotropics". It was first approved by the Food and Drug Administration (FDA) in September 1997 as a treatment for schizophrenia and in 2004 the antipsychotic was approved for the treatment of mania associated with bipolar disorder (manic-depressive illness) such as delusions, thought disorder, hallucinations, social withdrawal, lack of energy, apathy, and reduced ability to express emotion. (Bipolar disorder is a serious mental illness. According to the National Institute of Mental Health, it affects approximately 5.7 million adult Americans, or about 2.6 percent of the US. population age 18 and older every year and it is the sixth leading cause of disability in the world.)
Seroquel is also widely prescribed "off-label", meaning it is prescribed for conditions other than those originally approved by the FDA. (Although it is not illegal to prescribe
drugs off-label, it is illegal to market drugs
for non-FDA approved uses.) Seroquel is also prescribed to treat post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), general anxiety disorders, sleep disorders and depressive episodes associated with bipolar disorder, insomnia and other sleep disorders.
Seroquel Warnings and Side Effects
In 2003 the FDA required AstraZeneca, Seroquel's manufacturer, to add black box warnings to Seroquel's label after receiving several reports of increased diabetes rates among antipsychotic drug users. The reports indicated that Seroquel users face the highest risk of developing diabetes compared to other atypical antipsychotic medications. One study found that Seroquel users had 3.34 times more reported cases of diabetes compared to older first generation antipsychotic medications.
A later study reported the antipsychotic was associated with hyperglycemia, in some cases leading to ketoacidosis, coma, or death. In May 2005 the FDA ordered manufacturers of atypical (also known as 'second-generation'), antipsychotic medications--including Seroquel--to add another warning to the already existing black-box warnings, stating that the drugs are associated with an increased risk of death related to psychosis and behavioral problems in elderly patients with dementia.
In some cases, hyperglycemia and high blood sugar can lead to coma or death through dehydration, kidney failure, and cardiovascular disease. Diabetes mellitus can also lead to erectile dysfunction, blindness, gangrene and limb amputation.
Seroquel side effects also include neuroleptic malignant syndrome, which is characterized by fever and muscle rigidity. Other serious Seroquel side effects include tardive dyskinesia or uncontrollable movements.
As of September 2008, nearly 9,000 lawsuits had been filed against AstraZeneca, the maker of the blockbuster Seroquel. Almost 6,000 Seroquel lawsuits had been filed by injured victims in federal court and another 3,000 Seroquel cases were filed in various state courts involving 7,492 more plaintiff groups.
In federal court, the Seroquel litigation has been consolidated in a Multidistrict Litigation (MDL), which is centralized in the U.S. District Court for the Middle District of Florida. About 5,829 of the lawsuits are currently in the MDL, where they are being handled together for pretrial proceedings. If the cases do not resolve during pretrial litigation, the MDL procedures require that the cases be sent back to the court where they were filed for trial.
AstraZeneca says it has been served with complaints involving over 13,000 plaintiff groups. One legal expert predicts that AstraZeneca's defense costs will reach $10 billion. (Zyprexa litigation involved similar claims, i.e., diabetes and weight gain. Eli Lilly, the Zyprexa manufacturer, paid approximately $1.2 billion to settle about 30,000 individual Zyprexa lawsuits.)