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FDA Advisory Committee Recommendation on SEROQUEL XR Supplemental New Drug Applications
Date:4/8/2009

Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, hyperprolactinemia, 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 reported adverse reactions associated with the use of SEROQUEL XR vs. placebo in clinical trials for schizophrenia and bipolar disorder were 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%). The most commonly reported adverse reactions associated with the use of SEROQUEL vs. placebo in clinical trials for schizophrenia and bipolar disorder were somnolence (18%-57% vs. 8%-15%), dry mouth (9%-44% vs. 3%-13%), dizziness (9%-18% vs. 5%-7%), constipation (8%-10% vs. 3%-5%), asthenia (5%-10% vs. 3%-4%), abdominal pain (4%-7% vs. 1%-3%), postural hypotension (4%-7% vs. 1%-2%), pharyngitis (4%-6% vs. 3%), weight gain (5%-6% vs. 1%-3%), lethargy (5% vs. 2%), nasal congestion (5% vs. 3%), SGPT increased (5% vs. 1%), and dyspepsia (5%-7% vs. 1%-4%).

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

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