Seroquel—generic name quetiapine fumarate—was approved by the FDA in 1997 as an antipsychotic drug for treatment of schizophrenia and bipolar disorder.
Classified as a dibenzothiazepine derivative, Seroquel is considered a second generation antipsychotic drug, as distinct from the older types of psychotic drugs that were known for causing serious problems with motor control.
Seroquel is responsible for over $2 billion in annual sales for its maker, AstraZeneca.
Diabetes, Obesity, and Blood Sugar Imbalances
While Seroquel does carry decreased risks of side effects causing problems with motor control, studies have shown a strong correlation to use of Seroquel and other side effects such as diabetes, blood sugar imbalances, and obesity.
In a joint statement in the February 2004 issue of the journal Diabetes Care, four prominent medical societies—the American Psychiatric Association, the North American Society for the Study of Obesity, the American Diabetes Association, and the American Association of Clinical Endocrinologists—issued a warning naming Seroquel as a serious risk to patients as a result of its strong correlation to diabetes, dangerously high cholesterol levels, and obesity in patients taking the drug. One study showed that patients taking Seroquel were 3.34 times as likely to develop diabetes as those taking older, first-generation antipsychotics.
Increased Fatality in Elderly Dementia Patients
It has also been shown that second generation antipsychotics, including Seroqual, drastically increase the fatality rate among elderly patients prescribed the drug for dementia related disorders. Studies have shown that elderly patients prescribed second-generation antipsychotics have a fatality rate that is 160 to 170% greater than similar patients who were prescribed placebo, according to a review of 17 studies by the FDA.
As a result of these alarming statistics, the FDA asked that all manufacturers of second-generation antipsychotics include a black box warning—the strongest type of side effect warning available for prescription drugs—to their packaging.
Children and Seroquel
Seroquel is not officially approved by the FDA for treatment of any type of pediatric disorder. The only FDA-approved uses of Seroquel are for adult schizophrenia-related disorders, and adult rapid-cycling bipolar disorders.
Despite this, a disturbing review done of FDA data by USA Today in 2006 showed that at least 45 deaths of children under 18 listed atypical or second-generation antipsychotics such as Seroquel as the “primary suspect” in the death. Additionally, there were another 1,328 reports over other serious and even life-threatening side effects as a result of the drugs.
It is commonly acknowledged that events reported to the FDA usually only represent one to ten percent of actual cases. Depending on this standard’s accuracy, this would represent somewhere between 450 and 4500 deaths of children under 18 as a possible result of drugs such as Seroquel.
Off-Label Uses
Exacerbating the problems with the known physical side effects of Seroquel, use of Seroquel seems unusually concentrated on off-label uses. While it is perfectly legal for individual physicians to prescribe medications for uses not specifically approved by the FDA, it is explicitly illegal for drug manufacturers to market their drugs for these off-label uses.
While it has not been conclusively shown that AstraZeneca, the Seroquel manufacturer, has marketed Seroquel for these off-label uses, the frequency of off-label Seroquel prescriptions has led some to question whether AstraZeneca may have engaged in illegal marketing tactics.
In an analysis by Knight-Ridder Newspapers in 2004, it was estimated that over half of the prescriptions for Seroquel were for such off-label uses as:
- ADD, ADHD, and other behavioral problems in children
- Tourette’s Syndrome in children
- Insomnia
- Anxiety
- Autism
- Depression
- Parkinson’s Disease
How You Can Get Help
If you or a loved one was prescribed Seroquel and suffered damaging side effects, you owe it to yourself and to your family to seek the help of an experienced pharmaceutical injury attorney in your area. He or she will review your case with you, and help you determine how you can best go about getting the compensation you need for your medical bills, lost wages, pain and suffering, and other damages.
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