testosterone therapy injection

Here is a synopsis of 4 critical pieces of research on the possible dangers of testosterone therapy.

“Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” — published in the Journal of the American Medical Association (JAMA) in 2013.

Han Holding HeartThe authors sought to “assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease.” They looked at “8709 men with a total testosterone level lower than 300 ng/dL” and concluded that “Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes,” with the caveat that “the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown.”

“Adverse Events Associated with Testosterone Administration” — published in the New England Journal of Medicine in 2010.

The researchers examined 209 “community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter” and found that “in this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events.” However, they did present the caveat that “The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.”

“Testosterone Lab Testing and Initiation in the United Kingdom and the United States, 2000 to 2011” — published in 2014 in the Journal of Clinical Endocrinology & Metabolism.

Old Man NewspaperThe researchers “evaluated commercial and Medicare insurance claims from the United States and general practitioner healthcare records from the United Kingdom for the years 2000 through 2011.” They concluded that “Testosterone testing and use has increased over the past decade, particularly in the United States, with dramatic shifts from injections to gels. Substantial use is seen in men without recent testing and in US men with normal levels. Given widening use despite safety and efficacy questions, prescribers must consider the medical necessity of testosterone before initiation.”

FDA Safety Alert

On January 31, 2014, the Federal Drug Administration issued a safety alert stating that men taking FDA-approved testosterone products might be at heightened risk for stroke, heart attack, pulmonary embolism, other clots and death.

“The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”