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FDA Alert on seroquel from WebMD Medical News:
Check with your physician if you have any of the following:
Conditions:
Abnormal Movements of Face Muscles and Tongue, Neuroleptic Malignant Syndrome, Tobacco Smoking, Epileptic Seizure, Cataracts, Metabolic Syndrome X, Dementia in an Elderly Person, Heart Attack, Disease of Inadequate Blood Flow to the Heart Muscle, Abnormal Heart Rhythm, Chronic Heart Failure, Any Disorder of the Blood Vessels of the Brain, Blood Pressure Drop Upon Standing, Abnormally Low Blood Pressure, Liver Problems, High Blood Sugar, Decreased Blood Volume, Underactive Thyroid, Diabetes, High Amount of Fats in the Blood, Extreme Loss of Body Water, Overweight, Having Thoughts of Suicide
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Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including SEROQUEL. Rare cases of NMS have been reported with SEROQUEL. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.
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Cardiovascular System
Frequent: palpitation; Infrequent: vasodilatation, QT interval prolonged, migraine, bradycardia, cerebral ischemia, irregular pulse, T wave abnormality, bundle branch block, cerebrovascular accident, deep thrombophlebitis, T wave inversion; Rare: angina pectoris, atrial fibrillation, AV block first degree, congestive heart failure, ST elevated, thrombophlebitis, T wave flattening, ST abnormality, increased QRS duration
Cholesterol and Triglyceride Elevations
In schizophrenia trials, the proportions of patients with elevations to levels of cholesterol ≥240 mg/dL and triglycerides ≥200 mg/dL were 16% and 23% for SEROQUEL treated patients respectively compared to 7% and 16% for placebo patients respectively. In bipolar depression trials, the proportion of patients with cholesterol and triglycerides elevations to these levels were 9% and 14% for SEROQUEL treated patients respectively, compared to 6% and 9% for placebo patients respectively.
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January 30, 2004
Dear Health Care Provider,
AstraZeneca Pharmaceuticals LP would like to inform you of important labeling changes regarding SEROQUEL ® (quetiapine fumarate). The FDA has asked all manufacturers of atypical antipsychotic medications, including AstraZeneca, to add a Warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including SEROQUEL.
Accordingly, the SEROQUEL Prescribing Information has been updated with the addition of the following information:
WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Seroquel. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
Patients with risk factors for diabetes