Label Changes for:

Seroquel XR (Quetiapine fumarate) Extended-release Tablets

April 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

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.

 

Hide
(web1)