Testosterone Therapy and Low T – “Does Anybody Really Know What Time It Is?”

Low T v2The Food and Drug Administration (FDA) will now be requiring pharmaceutical manufacturers to label testosterone products with a warning that says that the use of this product is associated with an increased risk of blood clots in the veins. These venous emboli can break off and travel downstream causing lung emboli (pulmonary emboli) and even strokes. It had long been known that in men with polycythemia, a thickening of the blood due to increased red blood cells which is a side effect of testosterone therapy, have an increased risk of venous thrombosis.

The study of the effect of testosterone on veins is independent of the current FDA evaluation of the effect of testosterone on arterial clots, coronary artery disease and stroke. A Veterans Affair (VA) study showed a 29% increased risk of those events in veterans taking testosterone. A 2.19 fold higher risk of heart attack in older men and a 2.90 fold elevated risk in younger men with pre-existing heart disease was noted in another VA study. This data was refuted by testosterone advocates in their industry in an observational study suggesting a decreased risk of heart disease in users.

Testosterone supplementation is clearly indicated in criteria outlined by the American College of Endocrinology for hypogonadism. This requires measurement of the patient’s early morning testosterone level on 2 separate occasions. If the value is below a certain level supplementation is appropriate to restore your testosterone to normal functional levels. The problem is that anti-aging advocates have created a fire storm of outpatient enhancement clinics blitzing neighborhoods with advertising that supplementing your low but within the normal range testosterone enhances your quality of life, reduces unwanted body fat and invigorates the patient. There have been insufficient randomized controlled trials to answer the question of whether this practice makes you feel better but is detrimental to your health or if this is something aging men need to think about trying. The FDA investigation is now being joined by the European Medicine Agency to try and assess benefits versus risk of this form of therapy. At the recent meeting of the American Academy of Urology a lively panel debate was held reviewing what is known about testosterone therapy and whether current usage had reached abusive levels? There was broad agreement that more research is needed and until then the guidelines of the American College of Endocrinology should be the gold standard for initiating testosterone therapy safely.

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