Safety

Clinical considerations listed in FDA-approved labeling for 5-ARIs1-3:

Adverse reactions

• Sexual dysfunction, such as impotence, decreased libido, erectile and ejaculatory disorders, and decreased ejaculate volume

• Breast disorders, including breast enlargement and tenderness

• Skin reactions, such as rash

Warnings and precautions

• High-grade prostate cancer: The FDA labels for 5-ARIs include a warning that 5-ARIs may increase the risk of high-grade prostate cancer.1-3 This warning, issued in 2011, is based on two prevention trials that observed a higher incidence of high-grade disease in patients receiving 5-ARIs.6-8 Subsequent analyses have offered differing interpretations of the initial findings, including whether a detection bias may have influenced reported outcomes.9-19

• Prostate-specific antigen (PSA) adjustments: The FDA labels state that 5-ARIs decrease serum PSA levels by ~50%.1-3 Because PSA is suppressed, a new baseline may be established after >3 months for dutasteride and >6 months for finasteride, with continued PSA monitoring periodically.*1-3

  To interpret PSA values in patients receiving a 5-ARI for >3 months (dutasteride) or 6 months (finasteride), the prescribing information recommends doubling the measured PSA for comparison with values in untreated patients.1-3 Any confirmed increase in PSA, regardless of whether the value is within the normal range, warrants evaluation.1-3

• Blood donation: Patients should not donate blood until ≥6 months after their last dose of dutasteride and ≥1 month after their last dose of finasteride.20

• Risk for pregnant women: Women who are pregnant or may be pregnant are advised not to handle dutasteride or finasteride capsules due to the potential risk to a male fetus.1-3

• Consideration of other urological conditions: Prior to initiating a 5-ARI, consideration is given to urological conditions.1,2

For full prescribing information, see the FDA-approved labels for finasteride and dutasteride.

Safety and monitoring recommendations in this section are derived from FDA-approved labeling for dutasteride (0.5 mg) and finasteride (5 mg), which were developed in the context of benign prostatic hyperplasia. FDA-approved finasteride labeling includes postmarketing reports of depression and suicidal ideation, primarily described in the context of finasteride 1 mg.