Media Contact: Elaine Wohl
516-465-2615/2600
ewohl@nshs.edu

LAKE SUCCESS, NY-- The prolonged use of a common class of medications used to treat enlarged prostate and lower urinary tract symptoms, known as 5 alpha reductase inhibitors (5-ARI), also called finasteride and dutasteride, may result in the increased risk of diagnosis of high grade prostate cancer, the U.S. Food and Drug Administration (FDA) warns.

“Based on the results of the new analysis of data and recommendations from FDA, patients, especially those younger than 75 years old, should be counseled regarding the potential risks of high grade prostate cancer associated with the long term use of 5-ARIs,” said Louis Kavoussi, MD, chairman of the department of urology of the North Shore-LIJ Health System, and director of the health system’s Arthur Smith Institute for Urology  “While these medications are important in the treatment of benign prostatic hypertrophy related urinary tract symptoms, healthcare providers and patients should be cautious in any long term off label use of 5-ARIs.”

The recent FDA Drug Safety Communication was based on data analysis from two large randomized, placebo controlled trials. In these trials, more than 27,000 men were randomly assigned to receive either a 5-ARI or placebo with the goal to prevent the diagnosis of prostate cancer.

“While the overall incidence of prostate cancer was reduced by 25 percent, the analysis revealed a higher incidence of high-grade cancers in the group of men assigned to the study drug,” said Manish Vira, MD, director of the urologic oncology fellowship program at the North Shore-LIJ Health System . “As a result, the FDA revised the labeling of those medications to include the warning of the ‘increased risk’ of being diagnosed with a more serious form of prostate cancer. We want to be sure that physicians and patients are aware of the new warnings from the FDA. We are advising that any patient currently using or considering starting the medication should discuss these concerns with their physician.”

The FDA communication further advises healthcare professionals that:

1. 5-ARIs are not approved for the prevention of prostate cancer
2. 5-ARIs may increase the risk of high grade prostate cancer
3. Prior to initiating therapy with 5-ARIs, healthcare professionals should perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH).

The Arthur Smith Institute for Urology, part of the North Shore-LIJ Health System’s Center for Advanced Medicine, located in Lake Success, NY, is dedicated to the treatment of urological disease through innovative surgical procedures, diagnostics, and medical care. The full-time staff, under the direction of the chairman, Dr. Louis R. Kavoussi, represents international leadership in urology.