Seroquel is the brand name for the generic drug quetiapine, shown to be effective in treating certain mental disorders. Although doctors have been prescribing it for Alzheimer's disease and other dementia for years, the Food and Drug Administration has not approved the drug for that use. Seroquel is associated with several serious side effects.
Function
Produced by AstraZeneca Pharmaceuticals, Seroquel affects neurotransmitters including serotonin and dopamine. It is effective in treating symptoms of schizophrenia and acute manic episodes of bipolar disorder.
History
In 2004, the FDA issued alerts that Seroquel increases the risk of hyperglycemia and diabetes, and in 2005, issued an alert that this drug has been associated with higher risk of death in older patients with dementia. The FDA asked AstraZeneca to add warnings to the product labeling.
Warning
Over 15 clinical studies specific to elderly people with dementia link Seroquel to an increased risk of death from heart failure or infections such as pneumonia. The drug has been shown to cause severe anger in some users, a condition called "Seroquel anger." This effect is worst in elderly patients with dementia. Studies have indicated that Seroquel usage can worsen cognitive function and other Alzheimer's symptoms. Researchers in England found that dementia patients taking Seroquel experienced cognitive decline and excessive anger at twice the rate of patients taking a placebo.
Significance
In December 2008, documents filed in a Florida federal court indicated that AstraZeneca was aware since at least 2000 that this drug causes diabetes. The company's clinical trials showed that 2.4 percent of people with normal blood sugar developed high enough blood sugar levels to be classified as diabetic after one year of Seroquel use. Only 1.4 percent of patients taking a placebo had similar raised blood sugar. Statistically, it is nearly 70 percent more probable that people taking Seroquel will develop diabetes.
Considerations
Seroquel has been linked to neuroleptic malignant syndrome, a central nervous system condition which requires emergency medical attention and can be fatal. Symptoms include fast or abnormal heartbeat, sweating, muscle stiffness, high fever and confusion. Seroquel also has been associated with tardive dyskinesia, a serious condition with symptoms of uncontrollable repetitive movements of the face and tongue. Seroquel can have side effects of low blood pressure, cataracts, high cholesterol, abnormal thyroid activity, seizures, swallowing difficulty and liver impairment.
As of 2008, AstraZeneca Pharmaceuticals faces about 15,000 lawsuits in regard to Seroquel.
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