Tag Archive | "Propecia"

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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Benign Prostatic Hyperplasia and Male Pattern Baldness Drugs Make Men Impotent

Sometimes the “cure” can truly be worse than the disease.  Recently, a major drug often prescribed for the benign condition called benign prostatic hyperplasia (BPH) has been found to produce life altering side effects in men.  These side effects include loss of sex drive, impotence, depression, and gynecomastia, or the development of breasts in men.

Physicians have been recommending medications in the group known as 5a-reductase inhibitors (5a-RIs) for years to treat BPH.  Benign prostatic hyperplasia is a common condition affecting the prostate gland, leading to an enlargement of the gland due to aging.  BPH is benign and does not indicate prostate cancer, although it does cause symptoms such as more frequent urination and urinary hesitancy.  Further, the condition does affect about 75% of men by the time they are 80 years old; however, less than half ever have BPH symptoms that are painful or clinically significant.

Despite the benign nature of BPH, drugs like those in the 5a-RI group are still diligently prescribed.  Because of the common recommendation, an unexpected side effect of these drugs began to emerge:  balding men began to grow their hair back.  With this seemingly innocent new discovery came an even more popular demand for the 5a-RI known as finasteride (Propecia).  With patient demand, physicians handed Propecia out to many young men who had no BPH problems in order to fight male pattern baldness.  But now far less welcome side effects than hair growth are also emerging.

The Boston University School of Medicine (BUSM), in collaboration with colleagues at Lahey Clinic and from Denmark and Germany, produced a study indicating that 5a-RIs produce significant adverse effects in some men including loss of libido, impotency, ejaculatory dysfunction, depression, and the growth of breasts in men.  And these side effects do not always go away when the drugs are stopped.  Extreme caution is now placed on these drugs, and physicians must be careful when prescribing 5a-RIs therapy for BPH patients or for male pattern bald patients.

Scientists have noted that the side effects of two specific 5a-RIs, finasteride and dutasteride, have received minimal attention despite the fact that such side effects are life altering, diminish sexual function, take an emotional toll on the patients and their partners, and decrease the quality of life.

“Honest and open discussion with patients to educate them on these serious issues must be pursued prior to commencing therapy because, in some patients, these adverse effects are persistent and may be prolonged and patients do not recover well after discontinuation from drug use,” said lead author Abdulmaged M. Traish, MBA, PhD, a professor of biochemistry and professor of urology at BUSM.

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