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FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
Date:10/10/2008

istered to the patient increase. TD may remit, partially or completely, if antipsychotic treatment is withdrawn. Quetiapine should be prescribed in a manner that is most likely to minimize the occurrence of TD.

Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, hyperlipidemia, and possibility of suicide attempts. Examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment. The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high risk patients should accompany drug therapy.

The most commonly observed adverse reactions associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia and bipolar disorder somnolence (25-52% vs. 10-13%), dry mouth (12-37% vs. 1-7%), constipation (6-10% vs. 3-6%), dyspepsia (5-7% vs. 1-4%), dizziness (10-13% vs. 4-11%), orthostatic hypotension (7% vs. 5%), weight gain (7% vs. 1%), increased appetite (12% vs. 6%), fatigue (6-7% vs. 2-4%), dysarthria (5% vs. 0%), and nasal congestion (5% vs. 1%).

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 XR. (http://www1.astrazeneca-us.com/pi/seroquelxr.pdf)

About Bipolar Disorder

Approximately 8 million American adults may be affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.(3,4) Bipolar disorder consists of recurring episodes of mania and depression.(2) B
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