FDA Issues Warning about 5-ARIs’ Association with High-Grade Prostate Cancer

 

Based on results of the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, the US Food and Drug Administration (FDA) has updated the Warnings and Precautions sections of the labels for the 5-alpha reductase inhibitor (5-ARI) drug class. These trials showed that daily use of finaseride and dutasteride reduced overall incidence of prostate cancer (mainly low-grade), but increased the incidence of high-grade prostate cancers.

 

Treatment with finasteride 5 mg daily increased the incidence of Gleason score of 8 to 10 prostate cancers (1.8%) compared with placebo (1.1%). Similarly, treatment with dutasteride 0.5 mg daily also increased this risk compared with placebo (1% vs 0.5%, respectively).

Although the risk is low, providers should weigh these potential risks against the benefits of these drugs during treatment planning.

 

The drugs included in this warning are:

  • Finasteride: Proscare, Propecia
  • Dutasteride: Avodart, Jalyn (in combination with tamsulosin).

 

Read the FDA Safety Communication:

http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm

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Last modified: July 22, 2021