Clozaril (clozapine) - Feb 20, 2002
February 20, 2002
Audience: Psychiatrists, Pharmacists
FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections of the prescribing information (PI) for Clozaril (clozapine) as follows: (1) The previously existing BOXED WARNING has been relocated to the beginning of the PI and revised to advise health care providers of the association of myocarditis with clozapine therapy; (2) A subsection has been added to the WARNINGS section entitled "Myocarditis" to provide data and clozapine treatment guidelines related to this issue.[Feb 20, 2002 Letter - Novartis] PDF Format
[Feb 20, 2002 Revised Package Insert - Novartis] 112 kb PDF Format
