Market Name: Seroquel

Generic Name: Quetiapine fumarate

Seroquel, an anti-psychotic treatment for schizophrenia and acute bipolar disorder, has been shown to cause an increase in suicidal feelings and behavior in children and adolescents. While the FDA acknowledges that depression and other psychiatric disorders themselves are associated with increased risk of suicidal behavior, studies have shown that atypical antipsychotic drugs such as Seroquel have the potential to greatly increase this risk. A black box warning was added to Seroquel’s packaging in October of 2006.

Previously, the FDA warned that studies of elderly patients with dementia-related psychosis revealed an increased risk of death (1.6 times that of placebo) with use of Seroquel. This warning was added in April 2005.

Black Box Warning Date: October 2006

FDA Link: Seroquel