Label Changes for:
Casodex (bicalutamide) tablet
September 2010
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010
WARNINGS AND PRECAUTIONS
Hepatitis
- Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Casodex.
