Seroquel is an atypical antipsychotic medication manufactured by AstraZeneca. The FDA approved Seroquel in September 1997 to treat schizophrenia and bipolar disorder. Unfortunately, Seroquel use is linked to several rare but dangerous side effects including diabetes, Tardive Dyskinesia, and Neuroleptic Malignant Syndrome. Seroquel’s label includes warnings for these serious side effects. 

Seroquel FDA Warnings

The FDA required AstraZeneca, Seroquel’s manufacturer, to add black box warnings to Seroquel’s label in 2003 and again, in 2005. A black box warning is the strongest action the FDA can take short of a recall.

Seroquel 2003 FDA Warning

In 2003, the FDA ordered atypical antipsychotic drug manufacturers to add a black box warning to drug labels on various drugs, including Seroquel, warning users of the increased risk of diabetes (atypical antipsychotic medications include Seroquel, Clozaril, Risperdal, Zyprexa, Geodon, and Abilify).

The FDA ordered this warning after receiving several reports of increased diabetes rates among antipsychotic drug users. The reports indicate that Seroquel users face the highest risk of developing diabetes compared to other atypical antipsychotic medications. One study found that Seroquel users had 3.34 times more reported cases of diabetes compared to older first generation antipsychotic medications.

Seroquel 2005 FDA Warning

In April 2005, the FDA informed AstraZeneca (along with other atypical antipsychotic medications’ manufacturers) that it must add a new black box warning to Seroquel’s label. The black box warning was required to inform health care professionals and patients about the increased mortality risk in elderly patients taking Seroquel to treat dementia. Seroquel is not FDA approved to treat dementia, however, many doctors prescribe Seroquel as effective treatment for psychotic symptoms.

The FDA ordered a black box warning after studies revealed an increased risk of death in elderly patients with dementia. Seventeen studies analyzed 5,377 elderly patients with dementia-related disorders. Some patients in the studies took atypical antipsychotic medications and the remainder used various placebo treatments. The studies concluded that the risk of death in patients taking atypical antipsychotic medications were 1.6 to 1.7 times greater than in the placebo treated patients. Most deaths appeared to be from heart failure or pneumonia.

Information on Seroquel Warnings

If you would like more information about Seroquel’s warnings, or if you or a loved one has been injured by Seroquel, please contact us today.

  • Bernstein Liebhard LLP is no longer accepting Seroquel cases.

Published November 17, 2011 by