Archive | April, 2011

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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Research Underway for FDA Approved Investigational Medication for Prostate Cancer

Men naturally produce the male hormone testosterone which stimulates the prostate cancer cells.  Constantly suppressing the testosterone can treat prostate cancer however this diminishes quality of life by causing loss of sexual interest, impotence, hot flashes, decreased mental ability, fatigue and even depression. In an effort to turn this around, patients are now being enrolled at Florida Urology Physicians to evaluate the role of a new method of suppressing cancer growth.

The study being conducted by Dr. Barry Blitz evaluates the role of an FDA investigational medicine that has been successfully treating prostate cancer to allow men to live years with fewer side effects than current therapies.

To qualify as a study participant, men must have been treated for prostate cancer and have a rising Prostate Specific Antigen (PSA).  Study participants can receive study related exams, lab tests, and study medications at no charge.  They are also compensated for their involvement.

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Prostate Growth Not Affected by DHT

According to the study finding published in the Annals of Internal Medicine, daily use of transdermal dihydrotestosterone (DHT) treatment over two years had no beneficial effect on prostate growth but was associated with a reduction in spinal bone mineral density (BMD) .

In the study 114 men aged 50 years and older with no known prostate disease received the hormone therapy or placebo for 2 years to determine whether long-term administration of a nonamplifiable pure androgen would reduce prostate growth.  The result – in all men, over  time average prostate size increased with total prostate volume growing by 29% and central prostate volume by 75% with a 15% hike in serum PSA level.

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Infections Secondary to Transrectal Prostate Needle Biopsy

If prostate cancer is suspected, a prostate needle biopsy is recommended. This surgical procedure takes about 15 minutes and is usually performed in the urologist’s office.

Post biopsy infections are very rare, occurring in less than 1% of patients however research reports suggest that the rate of infectious complications, including sepsis may be increasing. Recently published news articles highlighted these findings, and it is important for urologists to be aware of this issue.

According to the AUA Best Practice Statement on Urologic Surgery Antimicrobial Prophylaxis, the antimicrobial of choice prior to prostate needle biopsy is a fluoroquinolone or a second- or third-generation cephalosporin. Alternative agents include an aminoglycoside plus metronidazole or clindamycin. Oral fluoroquinolones are the most commonly used agents in clinical practice.

The primary reason for post-biopsy infections appears to be the presence of fluoroquinolone-resistant organisms in the fecal flora. Risk factors which predict the presence of resistant bacteria are not well defined, but may include previous fluoroquinolone administration, and patient occupation as a healthcare worker. Prior to performing a transrectal prostate biopsy, urologists should consider broadening the antimicrobial coverage in patients with these risk factors. Furthermore, in men with signs of an infection after prostate needle biopsy, the presence of resistant bacteria is likely and broad-spectrum treatment should be initiated.

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Label Switch in Pfizer Drugs

There is a possible label switch in two of Pfizer’s drugs – an antidepressant and a drug used to shrink the prostate.  This prompted Pfizer to do a subsidiary recall on both drugs.

The affected drugs are both in generic formulation -  Citalopram is an antidepressant and Finasteride is used to treat benign prostatic hyperplasia (BPH).

It is said that only one lot was affected.  Bottles labeled as Citalopram Lot # F10510058-A may contain Finasteride.  The lot number involves Citalopram in 100-count  bottles of 10-mg tables and Finasteride In 90-count bottles of 5-mg tablets.

Greenstone LLC, the Pfizer unit selling the products stressed that patients taking the wrong medications may be at risk for serious side effects.  Patients who discontinue Citalopram abruptly may experience withdrawal symptoms and/or worsening depression. Women who are, or may become pregnant, should not take or handle Finasteride due to possible risk of abnormalities to the external genitalia of a developing male fetus.

Patients should check their bottles of either drug with this lot number on the label should return the products to the pharmacy.

The recall stemmed from the possibility that incorrect labels have been placed on the bottles by a third party manufacturer.

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