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September 30, 2014 12:39 ET

Low Testosterone: FDA Panel Calls for Reduction in Low T Prescriptions

David B. Samadi, an Expert in Robotic Prostate Surgery, Discusses the Prevalence of Low T Drugs and the Associated Cardiac and Prostate Risks

NEW YORK, NY--(Marketwired - Sep 30, 2014) - According to a recent U.S. Food and Drug Administration (FDA) advisory panel vote, drugs for low testosterone (Low T) should only be prescribed to men with genetic disorders or tumors that cause reduced testosterone levels. While the FDA has not set such restrictions, the panel's recommendation is in stark contrast to the growing use of such drugs for everything from erectile dysfunction (ED) to reduced energy levels to depression.

Currently, Low T medication is taken by men of all ages to treat a wide range of physical and emotional symptoms. Prostate cancer expert, David B. Samadi, MD, Chairman of Urology and Chief of Robotic Surgery at Lenox Hill Hospital, is concerned that Low T is being used as a catchall diagnosis. The result, he says, is over-prescribing and under-analyzing. 

"The dramatic climb in testosterone replacement therapy (TRT) prescriptions is the result of a quick-fix mentality," said Dr. Samadi. "Unfortunately, low testosterone medication has fallen into a gray area and is now being used for issues such as low sex drive, depression, and lack of energy. Very often these issues have other medical causes. Men deserve a deeper exploration, not a symptom band-aid."

Cardiac risks linked to testosterone therapy

In November 2013, a cohort of more than 8,000 Veterans Affairs patients were found to have significantly increased risk of adverse outcomes, including stroke, when using testosterone therapy after a coronary angiography: http://jama.jamanetwork.com/article.aspx?articleid=1764051

A January 2014 testosterone therapy study of 55,000 men found that those over age 65 may double their risk of heart attack by consuming these supplements, while younger men with pre-existing heart conditions could triple their risk. In younger men, the greatest risk of heart attack was seen at treatment commencement. The study was published in PLOS One: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805 

In June 2014, the FDA began requiring manufacturers of testosterone products to include a general warning on drug labels pertaining to the risk of blood clots in veins.

Prostate health and testosterone therapy

Just this month, the Endocrine Society advised the FDA that only men who meet the diagnostic guidelines for hypogonadism should be given testosterone therapy. The Society frequently voices its concern over the volume of men being prescribed testosterone replacements without clear medical need. Like Dr. Samadi, they are particularly cautious about men with existing benign prostatic disease, as testosterone often increases the size of the prostate and causes decreased urination.

Low testosterone can be difficult to diagnose. Testosterone levels fluctuate throughout day, requiring a series of blood tests to achieve a true reading. Dr. Samadi advises having the first testosterone blood draw at 8:00 AM; if the initial reading warrants further exploration, the test should be repeated on separate mornings to establish an overall measure. Normal testosterone is indicated within a range and few men are consistently below normal levels. Another key consideration is the natural decline of testosterone production with age.

"Even for men with truly low testosterone levels, drugs may not be the answer. More significant medical conditions may exist, including thyroid, liver, or pituitary gland issues. Erectile dysfunction can have a wide range of causes, including prostate cancer. Simply medicating a patient doesn't always treat the primary problem," stressed Dr. Samadi. 

Dr. Samadi encourages men to seek a thorough diagnosis before beginning testosterone therapy. A review of testosterone levels can easily be included with annual screenings, such as the prostate-specific antigen (PSA) blood test for prostate cancer.

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