FDA Warns 5-alpha reductase inhibitors (5-ARIs) may increase risk of high-grade prostate cancer

The U.S. Food and Drug Administration (FDA) issued a warning today about several drugs that can increase the risk of prostate cancer.

The drugs are known as 5-alpha reductase inhibitors (5-ARIs) and are a class of prescription medication used in the treatment of the symptoms of benign prostatic hyperplasia (BPH) in men. The FDA statement says that the drugs affected by today's warning are:

Drugs in this class are finasteride (marketed as Proscar [finasteride 5 mg] and Propecia [finasteride 1 mg]) and dutasteride (marketed as Avodart). Dutasteride is also available in combination with tamsulosin under the brand name Jalyn.

Avodart, Jalyn, and Proscar are indicated for the treatment of BPH symptoms in men with an enlarged prostate. Avodart and Proscar are also approved to reduce the risk of urinary retention or surgery related to BPH.

Propecia is only indicated for the treatment of male pattern hair loss in men.

The lables of all 5-ARIs are being revised based on two studies that examined rather Proscar and Avodart reduced the risk of prostate cancer. The studies confirmed an overall reduction in the risk of lower-grade forms of prostate cancer, however, they also showed an increased risk for high-grade prostate cancer.

The FDA advises anyone taking 5-ARIs to consult their healthcare professionals about the risks and benefits of the medications and possible alternate medications that might have the same benefits. Men are encouraged to not stop taking medications unless directed to by their healthcare professional.