radaronline.com/exclusives/2014/11/robin-williams-coroners-report-death-suicide/
information for SEROQUEL.
SEROQUEL®
(quetiapine
fumarate) Tablets
Initial US Approval: 1997
WARNING: INCREASED MORTALITY
IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED
PSYCHOSIS
•Antipsychotic
drugs are associated with an increased risk of death (5.1)
•
Quetiapine is not approved for elderly
patients with Dementia-Related Psychosis (5.1)
WARNING: SUICIDALITY AND
ANTIDEPRESSANT DRUGS
See Full Prescribing
Information for complete boxed warning.
•
Increased risk of suicidal thinking and
behavior in children, adolescents and young adults taking antidepressants for
major depressive disorder and other psychiatric disorders
Alert for Healthcare Professionals: Quetiapine (marketed as Seroquel)
9/2006: The issue described in this alert has been addressed in product labeling.
FDA Alert [4/11/2005]: Increased Mortality in Patients with Dementia-Related Psychosis
FDA
has determined that patients with dementia-related psychosis treated
with atypical (second generation) antipsychotic medications are at an
increased risk of death compared to placebo. Based on currently
available data, FDA has requested that the package insert for Seoquel be
revised to include a black box warning describing this risk and noting
that this drug is not approved for this indication.
science_news/release/seroquel
parkinson-s-patients-still prescribed-antipsychotics-despite-warning-
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WebMD parkinsons-disease/antipsychotics-used-for-parkinsons-despite-warnings
Doctors continue to prescribe antipsychotic drugs to their patients with Parkinson's disease and psychosis, despite "black box" warnings from the FDA linking them to increased risk of death among patients with dementia, a study shows.
A black box warning is the strongest drug warning issued by the FDA.
"My sense is that the black box warnings don't
factor into decision making," says study researcher Daniel Weintraub,
MD, an associate professor of psychiatry at the University of
Pennsylvania.
The study is published in the Archives of Neurology.
The black box warning for antipsychotics says the
drugs are associated with an increased risk of death for those with
dementia, which is common among people diagnosed with Parkinson's. Some
commonly prescribed antipsychotics also worsen symptoms of Parkinson's.
ENOUGH SAID!
