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Urology: 5-alpha Reductase Inhibitors May Increase High-Grade Prostate Cancer Risk

by Erin Moore

The U.S. Food and Drug Administration (FDA) has released a drug safety communication to alert healthcare professionals of an increased risk of high-grade prostate cancer associated with 5-alpha reductase inhibitors (5-ARIs).

5-ARIs are prescribed primarily for benign prostatic hyperplasia (BPH), but may also be used for urinary retention or male pattern hair loss. The new safety information is based on two large, randomized controlled trials that evaluated finasteride 5 mg daily versus placebo for seven years and dutasteride 0.5 mg daily versus placebo for four years. Both trials showed an overall decrease in prostate cancer risk due to decreased incidence of lower-grade cancers; however, the trials also showed increased risk of high-grade prostate cancer. The FDA advises weighing the known benefits against potential risks when deciding whether to initiate or continue 5-ARI treatment in men. The alert adds the following:

  • Evaluate patients for other urological conditions prior to treatment. Prostate cancer symptoms may mimic those of BPH.
  • Know that 5-ARIs can reduce prostate-specific antigen (PSA) values by 50 percent. Therefore, confirmed increases in PSA while on a 5-ARI may signal cancer even if that PSA value is within normal range.
  • Report any adverse events to the FDA MedWatch program at 1 (800) 332-1088.

Source: Food and Drug Administration. 2011. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. Published on June 9, 2011 on the FDA website.