The FDA notified 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).
The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is approved to treat male pattern hair loss.
The FDA recommends that prior to initiating therapy with 5-ARIs, doctors perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information.
It seems the FDA knows something about common medical practice as their recommendation implies that doctors do not do this on a reliable basis or perhaps not at all. That is positively scary.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
The most important differential (or other possible) diagnosis to eliminate when diagnosing BPH is prostate cancer. There is considerable irony at best in discovery of a link between serious prostate cancer and drugs such as Proscar, Avodart, and Jalyn which are approved to improve symptoms of BPH.
As for Propecia, a drug approved to treat male pattern hair loss, one has to wonder if the likelihood of developing serious prostate cancer will overcome the vanity that supports the market for this drug. This has always been a foolish drug, now it is foolhardy.