Label Changes for:

Propecia (finasteride) 1 mg tablet

March 2010

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) March 2010, March 2011 and June 2011

 

June 2011 

 

PRECAUTIONS

Increased Risk of High-Grade Prostate Cancer with 5-Alpha Reductase Inhibitors
  • Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of Propecia) 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%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, Avodart) (1% dutasteride vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

ADVERSE REACTIONS

  • During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with Proscar but no cases in men not treated with Proscar. During the 4-year placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with Proscar. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with Proscar, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
  • The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either Proscar (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, Avodart), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of Propecia by men is unknown.
  • No clinical benefit has been demonstrated in patients with prostate cancer treated with Proscar. Proscar is not approved to reduce the risk of developing prostate cancer.

 

March 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • depression

 

March 2010 

 

PRECAUTIONS 

Drug/Laboratory Test Interactions Other 
  • Studies with Proscar showed it may also cause decreases in serum PSA in the presence of prostate cancer.  Any confirmed increases in PSA levels from nadir while on Propecia 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 to therapy with Propecia may also affect PSA test results.

MEDICATIONS GUIDE 

What are the possible side effects of Propecia?
  • Because Propecia decreases PSA levels, changes in PSA levels will need to be carefully evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point should be carefully evaluated even if the test results are still within the normal range for men not taking Propecia. You should also tell your doctor if you have not been taking Propecia as prescribed because this may affect the PSA test results. For more information, talk to your doctor.

 

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