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U.S. Department of Health and Human Services

Safety

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Seroquel and Seroquel XR (Quetiapine Fumarate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis - In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects.  Seroquel/Seroquel XR is not approved for the treatment of patients with dementia-related psychosis.