Label Changes for:

Proscar (finasteride) 5mg Tablets

January 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

January 2013

ADVERSE REACTIONS

Postmarketing Experience
  • sexual dysfunction that continued after discontinuation of treatment, including ......

 

 

October 2010

 

ADVERSE REACTIONS

Post-marketing Experience
  • male breast cancer

PATIENT PACKAGE INSERT

What are the possible side effects of Proscar?
  • in rare cases, male breast cancer has been reported

 

March 2010

 

PRECAUTIONS

Effects on PSA and Prostate Cancer Detection
  • Any confirmed increases in PSA levels from nadir while on Proscar may signal the presence of prostate cancer and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with Proscar therapy may also affect PSA test results.

PATIENT PACKAGE INSERT (PPI)

  • New

 

 

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