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FDA Responds To AstraZeneca Citizen Petitions On Quetiapine Product Labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration (“FDA”) denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca (NYSE: AZN) to include in the labeling for SEROQUEL ® (quetiapine fumarate) tablets and SEROQUEL XR ® (quetiapine fumarate) extended-release tablets. AstraZeneca is evaluating the FDA’s decision and reasoning.

Indications

SEROQUEL XR is indicated in adults for (1) adjunctive therapy to antidepressants in major depressive disorder; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (4) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex; and (5) schizophrenia. SEROQUEL is indicated in adults for the treatment of (1) acute depressive episodes in bipolar disorder; (2) acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (3) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex, and (4) schizophrenia. SEROQUEL is also indicated (5) for the treatment of schizophrenia in adolescents (13-17 years of age) and (6) for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age). Patients should be periodically reassessed to determine the need for treatment and the appropriate dose.

Important Safety Information About SEROQUEL XR (quetiapine fumarate) and SEROQUEL (quetiapine fumarate)

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL XR and SEROQUEL are not approved for the treatment of patients with dementia-related psychosis. (See Prescribing Information for complete Boxed Warnings.)

SUICIDALITY AND ANTIDEPRESSANT DRUGS: Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of drug therapy or when changing dose. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL XR (quetiapine fumarate) is not approved for use in patients under the age of 18 years. SEROQUEL (quetiapine fumarate) i s not approved for use in patients under the age of 10 years. (See Prescribing Information for complete Boxed Warnings.)

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex, sometimes referred to as NMS, has been reported in association with administration of antipsychotic drugs, including quetiapine. Rare cases of NMS have been reported with quetiapine. 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. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment, and medical monitoring, and treatment of any concomitant serious medical problems.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including quetiapine. The relationship of atypical use and glucose abnormalities is complicated by the possibility of increased risk of diabetes in the schizophrenic population and the increasing incidence of diabetes in the general population. However, epidemiological studies suggest an increased risk of treatment-emergent, hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.

Hyperlipidemia: Undesirable alterations in lipids have been observed with quetiapine use. Increases in total cholesterol, LDL-cholesterol and triglycerides, and decreases in HDL-cholesterol have been reported in clinical trials. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of and periodically during treatment.

Weight Gain: Increases in weight have been observed in clinical trials. Patients receiving quetiapine should receive regular monitoring of weight.

In some patients, a worsening of more than one of the metabolic parameters of weight, blood glucose, and lipids was observed in clinical studies. Changes in these parameters should be managed as clinically appropriate.

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