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FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder
Date:5/14/2008

omnolence (34% vs 9%), dry mouth (19% vs 3%), asthenia (10% vs 4%), constipation (10% vs 5%), abdominal pain (7% vs 3%), postural hypotension (7% vs 2%), pharyngitis (6% vs 3%), and weight gain (6% vs 3%). The most commonly observed adverse reactions associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%).

In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose Greater Than or Equal To 126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean exposure 213 days) vs 4.6% in patients receiving placebo (mean exposure 152 days).

Please see Prescribing Information, including Boxed Warnings, for SEROQUEL.

About Bipolar Disorder

Approximately eight million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness. (4,5) Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterized by one or more manic or mixed episodes, often with episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. (6) In the long term, patients with bipolar I disorder experience depressive symptoms -- including prolonged periods of sadness, loss of energy, persistent lethargy, and recurring thoughts of death or suicide three times longer than manic symptoms (10,11) Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania. (12) Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagno
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SOURCE AstraZeneca
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