More and more men who are seeking hormone replacement therapy have been confused by two questionable studies that recently claimed testosterone therapy increases the risk of heart attack and stroke. To further complicate the landscape, the FDA embraced the two studies by issuing warnings about the risk of testosterone replacement therapy in men.
The FDA warning reads: The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.1, 2
With these warnings, the FDA surprised many experts in the field of male hormone replacement by ignoring the preponderance of evidence to the contrary. In direct contradiction to the FDA’s warning, the University of Texas Medical Branch, Galveston (July 2015) released findings of a study of over 25,000 men, age 66 and older. The large meta-analysis examined risks of testosterone therapy using Medicare case data of the older men. A control group of non-testosterone users was established.
The analyses showed testosterone therapy was NOT ASSOCIATED with an increased risk of heart attack or stroke. Further, high-cardiovascular risk testosterone users had a LOWER RATE OF HEART ATTACKS in comparison to equivalent patients who did not receive testosterone therapy.3
Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. From our perspective, patients lose when two highly-flawed medical studies with negative connotations are allowed to nullify an abundance of well-done studies with positive patient outcomes.
1 JAMA, Nov 2013, O’Donnell, Baron AE, et al. Observational study of older men in the U.S. Veteran Affairs health system- Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels
2 Journal.pone.0085805, Jan 29, 2014 DOI: 10.1371/, Finkle ,Greenland et al, Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
3 Annals of Pharmacotherapy, Jul 2015, Baillargeon, Urban, Kuo, Ottenbacher, Raji, Du, Lin and Goodwin