Tag Archive | "Proscar"

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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Dutasteride and Finasteride May Contribute to Irreversible Sexual Dysfunction in Men


Dutasteride (Avodart), a drug frequently prescribed to treat enlarged prostate and Finasteride (Proscar and Propecia); a drug frequently prescribed to treat hair loss may contribute to erectile dysfunction, depression and loss of libido.  Symptoms may even persist after the medication stopped.

This is according to a study led by Abdulmaged M. Traish, a professor of biochemistry and urology at Boston University School of Medicine.  The team searched for available medical literature for reports of sexual side effects associated with Finasteride and Dutasteride. Of the men taking the drugs, 8% reported erectile dysfunction and 4.2% reported reduced libido while those taking the placebo only 4% of men reported erectile dysfunction and 1.8% of men reported reduced libido. The researchers also noted that reduced ejaculation, reduced semen volume and depression were also reported by some men.

The drugs (Dutasteride and Finasteride) work by blocking androgen but androgen is needed for erectile function, libido and ejaculation, and for just feeling good.

Traish said “as a physician you have a responsibility to take the time and explain to your patient that maybe not everyone will have these side effects, but you may, and in some cases they are irreversible””.

Dr. Bruce R. Kava, an associate professor of urology at the University Of Miami Miller School Of Medicine agreed that “these drugs do cause some of these problems but they haven’t convinced me yet, based on the data, because they don’t have any long term data”.  He added that most urologists discuss potential side effects with their patients but usually “don’t discuss long term consequences that are irreversible, because most of us have not been aware of any long term problems from these drugs”.

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