FDA: 5-Alpha Reductase Inhibitors Associated with Increased Risk for High-Grade Prostate Cancer Diagnosis

The labels of 5-alpha reductase inhibitors (5-ARIs) are being changed to note an increased risk for being diagnosed with high-grade prostate cancer, the FDA announced on Thursday. The drugs (finasteride and dutasteride) are approved to treat benign prostatic hyperplasia and male pattern hair loss.

The announcement came after the FDA reviewed data from two prostate cancer prevention trials. In one, finasteride (given daily for 7 years) was associated with a higher frequency of prostate cancers with Gleason scores between 8 and 10, compared with placebo (1.8% vs. 1.1%). In the other, dutasteride (given daily for 4 years) was also associated with more high-grade cancers relative to placebo (1% vs. 0.5%).

The FDA recommends that physicians rule out prostate cancer before prescribing 5-ARIs for benign prostatic hyperplasia. Also, because these drugs lower prostate-specific antigen values, clinicians should be aware that if PSA increases while a patient is taking a 5-ARI — even if it is within the normal range — it may indicate the presence of prostate cancer