Label Changes for:
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Post Marketing Experience
- Adverse reactions reported since market introduction which were temporally related to quetiapine therapy include (addition of)… drug reaction with eosinophilia and systemic symptoms (DRESS),...
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.