US FDA warns on risk of more serious forms of prostate cancer with 5-ARI drugs

The US Food and Drug Administration has warned that the labeling for drugs used to treat enlarged prostate - 5-alpha reductase inhibitor (5-ARI) class of drugs - is being revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

This risk appears to be low, but health care 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, the FDA said.

Drugs involved are GSK’s Avodart and Merck’s Proscar