February 20, 2006
AstraZeneca (AZ) is seeking FDA approval for Seroquel to treat patients with depression related to Bipolar Disorder. Currently the drug is approved only to treat schizophrenia and manic episodes in bipolar patients. If the FDA does approve AZ's supplemental New Drug Application, Seroquel will be the only drug approved for both bipolar-related depressive and manic episodes. The application is based on the results of two studies which showed Seroquel significantly decreased depression compared to placebo and had minimal adverse effects.
February 01, 2006
Seroquel, also known as quetiapine fumarate, is an antipsychotic used to treat schizophrenia and symptoms of psychotic disorders such as hallucinations, delusions, and hostility. The U.S. Food and Drug Administration (FDA) approved Seroquel in 1997.
more...
April 30, 2005
The FDA is warning patients, medical professionals and caregivers of the unapproved off-label use of atypical anti psychotics in treating dementia in elderly patients. These drugs are not approved for this use, and studies have shown that elderly patients with dementia being treated with these drugs have a death rate between 1.5 and 2 times higher than those being treated with placebo.
Read the full FDA advisory.
March 31, 2005
View a copy of the "Dear Doctor" letter sent by AstraZeneca to healthcare providers in January 2004 alerting them of the Seroquel label change to include information about the antipsychotic's link to hyperglycemia and diabetes.