5-Alpha Reductase Inhibitors Increase Risk of High-Grade Prostate Cancer

Drug Alerts , News / September 21, 2016

The 5-alpha reductase inhibitor class includes finasteride and dutasteride, which are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn.The FDA notified healthcare professionals that new safety information is to be added to the Warnings and Precautions section of the labels for the 5-alpha reductase (5-ARI) class of drugs about the increased risk of being  diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

The new safety information is based on the FDA’s review of two large, randomized controlled trials – the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jayln are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH); Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate; while Propecia is approved to treat male pattern hair loss.

It is recommended that prior to initiating therapy with 5-ARIs; appropriate evaluation is to be performed to rule out urological conditions, including prostate cancer, which might resemble benign prostatic hyperplasia (BPH).

No Comments

Leave a Reply

%d bloggers like this:
Skip to toolbar