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U.S. Department of Health and Human Services

Safety

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Proscar (finasteride) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011 and April 2012

 

April 2012 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
The following additional adverse events have been reported in post-marketing experience
  • Erectile dysfunction (ED) that continued after discontinuation of treatment…
  • Male infertility and/or poor seminal quality have been reported…
  • Depression
  • Decreased libido that continued after discontinuation of treatment

 

June 2011

Summary View

 

  

WARNINGS AND PRECAUTIONS

Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection
  • In clinical studies, Proscar reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals.
  • For interpretation of serial PSAs in men taking Proscar, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while...
  • Proscar may also cause decreases in serum PSA in the presence of prostate cancer. The ratio of free to total PSA (percent free PSA) remains constant even under the influence of Proscar. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary. 
Increased Risk of High-Grade Prostate Cancer
  • Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%)…