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U.S. Department of Health and Human Services

Safety

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Seroquel (quetiapine fumarate)

Audience: Neuropsychiatric healthcare professionals

FDA and AstraZeneca notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Seroquel. FDA has asked all manufacturers of atypical antipsychotic medications, including AstraZeneca, to add this Warning statement to labeling.

[UPDATE - April 22, 2004 - Letter - AstraZeneca]
[January 30, 2004 - Letter - AstraZeneca]
[January 2004 Revised Label - AstraZeneca]