Label Changes for:
Jalyn (dutasteride and tamsulosin) capsules
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) – June 2011
WARNINGS and PRECAUTIONS
Increased Risk of High-grade Prostate Cancer
- revisions to the labeling regarding the risk of high-grade prostate cancer and the effect of Jalyn on serum prostate specific antigen (PSA) levels. It also provides updated information regarding male breast cancer and includes 4 year results from the CombAT study (ARI40005).