Label Changes for:
Gleevec (imatinib mesylate) Tablets
April 2011
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
5 WARNINGS AND PRECAUTIONS
5.4 Hepatotoxicity
5.12 Children and Adolescents
- ...growth retardation...
5.13 Tumor Lysis syndrome
6 ADVERSE REACTIONS
6.13 Postmarketing Experience
- ...growth retardation...
