The Food and Drug Administration (FDA) of the United States informed the public of new safety information for drugs called 5-alpha reductase inhibitors (5-ARIs). Men who take these drugs may have an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). The Warnings and Precautions section of the labels for all FDA-approved 5-ARIs has been revised to include information about this risk.
Q1. What should men do if they are currently taking 5-alpha reductase inhibitors (5-ARIs)?
A. Men who are currently taking 5-alpha reductase inhibitors (5-ARIs) should consult a healthcare professional to discuss the risks and benefits of these medications. Men should not stop taking their medication unless directed to do so by a healthcare professional.
Q2. How should men taking 5-ARIs be screened for prostate cancer?
A. There is no universally accepted screening test for prostate cancer, including high-grade prostate cancer. The most commonly used screening method is prostate-specific antigen (PSA) blood testing combined with a digital (finger) rectal exam.
A PSA test checks for elevated serum PSA levels, which may indicate the presence of prostate cancer. A digital rectal exam involves a healthcare professional inserting a lubricated, gloved finger into the rectum to feel for enlargement, hardness or growths.
It is important to note that 5-alpha reductase inhibitors (5-ARIs) decrease serum PSA levels by approximately 50%. Any confirmed increase in PSA in men taking 5-ARIs, even if the value is within the normal range for men not taking 5-ARIs, should be evaluated by a healthcare professional. Men taking 5-ARIs should discuss the need for prostate cancer screening with a healthcare professional.
Q3. Are there other medications to treat benign prostatic hyperplasia (BPH) or male pattern baldness?
A. Yes. Another class of medications called alpha-blockers is approved to treat the symptoms of BPH. Medications in the alpha-blocker class include tamsulosin (Flomax), doxazosin (Cardura), terazosin (Hytrin), alfuzosin (Uroxatral), and silodosin (Rapaflo). However, 5-ARIs are the only medications that have been shown to reduce the risk of urinary retention or surgery related to an enlarged prostate.
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