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U.S. Department of Health and Human Services

Safety

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Jalyn (dutasteride and tamsulosin) capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011 

Summary View

 

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).