IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.
AstraZeneca received notice on April 11, 2005, of the US Food and Drug Administration (FDA) request that the product labeling for all atypical antipsychotics, including SEROQUEL, be updated to include a boxed warning noting the increased risk of mortality in elderly patients with dementia-related psychosis taking these drugs, compared to patients taking placebo. The FDA proposed boxed warning also notes that these drugs are not approved for treatment of elderly patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood g
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23-May-2005