The U.S. Food and Drug Administration (FDA) has recently mandated a label change on 5-alpha reductase inhibitors (5-ARIs). This class of drugs, which includes finasteride and dutasteride, is available on the market as Proscar, Propecia, Avodart, and Jalyn. Proscar, Jalyn, and Avodart are intended to alleviate the symptoms of an enlarged prostate gland; Propecia treats male pattern hair loss; and Proscar and Avodart are also approved for a reduced risk of urinary retention or surgery that is related to an enlarged prostate.

The agency issued this label change after reviewing new information about the drugs’ safety. The Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) are the two large, randomized controlled trials that provided the data on the relationship between 5-ARIs and prostate cancer. These drugs have now been linked to a greater risk of being diagnosed with high-grade prostate cancer, which is the most serious form of prostate cancer.

The FDA now recommends that other urological conditions be ruled out through the use of the appropriate assessments before beginning treatment with 5-ARIs, for these conditions may imitate benign prostatic hyperplasia.