The FDA announced that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with 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 prescribing these drugs, ie, finasteride (Propecia, Proscar) and dutasteride (Avodart, and in combination with tamsulosin, Jalyn).
The new safety information is based on FDA’s review of two large, randomized controlled trials that demonstrated an overall reduction in prostate cancer diagnoses with finasteride and dutasteride treatment. However, this reduction was due to a decreased incidence of lower-risk forms of prostate cancer. ■