Testosterone Replacement Therapy: Controversy and Recent Trends

Ashley S. Brown, PharmD, BCPS, BCPP; Amy Murray, PharmD


US Pharmacist. 2019;44(8):17-23. 

In This Article

Abstract and Introduction


In recent years, testosterone replacement therapy (TRT) has received significant media attention, and the rate of testosterone use has increased notably. A reported association between testosterone use and increased occurrence of myocardial infarction and stroke prompted the FDA to issue a safety bulletin in 2014. Clinical hypogonadism is the only FDA-approved indication for TRT in men; it is not approved to treat age-related low testosterone. Although it is not indicated, TRT is often recommended to improve sexual function, bone density, body composition, muscle strength, mood, behavior, and cognition. The literature on the effectiveness of TRT for various conditions is largely mixed; therefore, current data on appropriate and potentially inappropriate use are important for pharmacists to keep abreast of and discuss with patients.


Recently, the use of testosterone replacement therapy (TRT) has received a lot of media attention. Although its use is growing, there is much debate regarding TRT's risks and benefits.[1] From 2008 to 2012 in the United States, spending on TRT increased from $1 billion to $2 billion, and from 2003 to 2013 there was a fourfold increase in the rate of TRT in men aged 18 to 45 years.[2] In 2013 and early 2014, two studies reported an association between TRT and increased occurrence of myocardial infarction and stroke, prompting the FDA to issue a safety bulletin on January 31, 2014.[3] This article will discuss appropriate TRT use, available formulations and cost, side effects, trends, and the pharmacist's role in patient education, including counseling points.