Clozaril (clozapine tablets)

April 7, 2004

Audience: Neuropsychiatric healthcare professionals

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

[April 1, 2004 Letter - Novartis]
[December 2003 Revised Label - Novartis]