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U.S. Department of Health and Human Services

Safety

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Risperdal (risperidone) Aug 2004

Audience: Neuropsychiatric healthcare professionals

FDA and Janssen revised the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Risperdal. MedWatch is posting a revised version of a letter originally distributed to health care professionals November 2003. FDA asked all manufacturers of atypical antipsychotic medications, including Janssen, to add this Warning statement to labeling.

[July 2004 - Letter - Janssen Pharmaceutica, Inc.]
[December 2003 - Revised Label - Janssen Pharmaceutica, Inc.]