In the News: FDA Warns of High-Grade Prostate Ca Risk with BPH Drugs

If you haven’t already heard, you may want to know what the FDA has to say about Proscar and Avodart.  There has been a warning  issued from the FDA regarding an increased risk of high-grade prostate cancer with the 5-alpha reductase inhibitors finasteride (Proscar) and dutasteride (Avodart), which are currently approved to treat benign prostatic hypertrophy.

The agency recently announced that it has updated the Warnings and Precautions section of labels for the class of drugs, including the branded products Propecia and Jalyn, to reflect the increased risk.

According to the acency, “This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men.”

Avodart, Jalyn, and Proscar are approved to treat symptoms of an enlarged prostate. Propecia, at a 1-mg dose, is approved to treat hair loss in men.

These drugs are not only linked to a higher incidence of high-grade tumors, but they have also demonstrated to be potentially chemopreventive.

The handling of low-grade prostate cancer is still in controversy to the urology community, mainly because it is still unknown whether the low-grade tumors would ever develop into high-grade tumors, but also because the method used to originally detect prostate cancer (the PSA test) is inexact.

How many people may this new information effect?  Well, according to the FDA, five million men received a prescription for a 5-ARI between 2002 and 2009.

Click here to learn more about the studies conducted.