"Increased Risk of Prostate Cancer” for the hair loss drug Propecia®
On June 9, 2011, the FDA issued a Drug Safety Communication1 about a class of drugs called 5-alpha reductase inhibitors, which includes the hair loss drug Propecia® (finasteride).
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
[6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been 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 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.
Two large clinical trials, known as PCPT and REDUCE, were conducted to assess the use of 5-ARIs for preventing prostate cancer. The PCPT trial raised concern at the FDA because patients being treated with finasteride had a slightly higher risk of developing high-grade prostate cancer than patients receiving placebo (1.8% versus 1.1%, respectively). It should be noted that although the title of the FDA's Safety Alert2 reads "Increased Risk of Prostate Cancer," the data on increased risk appear to relate only to the incidence of high-grade prostate cancer (Gleason Score 8-10).
While the “risk appears to be low,” the labels for drugs including Propecia®, Proscar® (finasteride) and Avodart® (dutasteride) are all being modified to warn patients of this potential risk. Propecia® is also associated with sexual side effects3 in some men, including less desire for sex and difficulty in achieving an erection.
The FDA has provided a page of Questions and Answers on the change in label information for 5-ARIs. Below are a few Q/A’s pertaining to the use of Propecia® for male pattern hair loss.
Q6. Does FDA believe the benefits of 5-alpha reductase inhibitors (5-ARIs) still outweigh their risks for the approved indications?
A. Yes. FDA believes that 5-ARIs remain safe and effective for their approved indications. Proscar and Avodart have been effective in controlling symptoms of benign prostatic hyperplasia (BPH), as well as in reducing the risks of acute urinary retention and the need for surgical intervention related to BPH. Healthcare professionals and patients are still encouraged to discuss the risks and benefits of 5-ARIs when deciding the best treatment for their disease.
FDA will continue its risk/benefit assessment of using 5-ARIs for the treatment for male pattern hair loss and will update the public when additional information is available.
Q9. 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.
Minoxidil is a topical product that is available over the counter in various formulations to treat male pattern hair loss.
1. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. June 9, 2011.
2. 5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer. June 9, 2011.
3. PROPECIA® labeling information, FDA website.