Tag Archive | "Jalyn"

FDA Calls for Warning Labels on Drugs for Enlarged Prostate


The U.S. Food and Drug Administration is calling for new warning labels on part of a class of medications used to primarily treat enlarged prostate called 5-alpha reductase inhibitors (5-ARI).  This new warning is based on the results of two large prostate cancer trials where it shows that the medications may raise the risk of developing an aggressive form of prostate cancer. The drugs involved include popular medications sold under brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

Propecia, a lower dose version of Proscar and is prescribed to treat hair loss in men is updating its label even though it was not included in the trials. FDA said “the applicability of the Avodart and Proscar studies to Propecia is currently unknown.”

FDA is advising doctors not to start patients on these drugs until prostate cancer and other urological conditions have been ruled out.  Prostate cancer can mimic the symptoms of an enlarged prostate.

Recent research has also shown that Proscar, Propecia and Avodart are all associated with increased risk of erectile dysfunction in men who take the medications.

According to FDA, between 2002 and 2009 almost 5 million men were prescribed one of these medications and of these nearly 3 million men were between the ages of 50 and 79.

“What both studies show conclusively is there is about 1% increase in being diagnosed with high-grade prostate cancer if you got these drugs even though you are less likely to get a low-grade cancer.  You have to weigh the 24% reduction against the 1% increased incidence of high-grade disease.” says Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital in Boston.  He added, “These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention.”

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