In a recent drug safety communication the FDA requires manufacturers of approved testosterone products to add labeling information about possible increased risk of heart attack and stroke. The American Urological Association (AUA) concludes that there is conflicting evidence about the impact of testosterone therapy on cardiovascular risks. Definitive studies have not been performed. The FDA drug safety communication cautions that benefits and risks of testosterone products for low testosterone due to aging are not clearly established. Hypogonadism is defined as biochemically low testosterone levels in the setting of a cluster of symptoms, which may include reduced sexual desire (libido) and activity, decreased spontaneous erections, decreased energy and depressed mood. Men with hypogonadism may also experience reduced muscle mass and strength and increased body fat. Hypogonadism may also contribute to reduced bone mineral density and anemia. Testosterone therapy is appropriate treatment for patients with clinically significant hypogonadism, including those with idiopathic clinical hypogonadism that may or may not be age-related, after full discussion of potential adverse effects. Patients should understand that treatment requires follow-up and medical monitoring. Testosterone therapy in the absence of hypogonadism is inappropriate.
Increased public awareness about hypogonadism has been stimulated by recent increases in availability and diversity of patient-acceptable forms of testosterone replacement options. Only FDA-approved medications should be used; over-the-counter preparations generally should be avoided based on lack of efficacy and safety data.
The management of hypogonadism should start with careful evaluation by a physician experienced in diagnosing and managing patients with hypogonadism. Many of the symptoms are non-specific and may be multifactorial in origin. Hence, symptoms may not be necessarily linked to hypogonadism alone. This fact needs to be considered in the overall evaluation. The diagnosis should be made only after taking detailed medical history, physical examination, and obtaining appropriate blood tests. Testosterone therapy should not be offered to men with normal testosterone levels. Testosterone therapy is never a treatment for infertility, and may cause infertility.
The AUA is also concerned about the risks associated with misuse of testosterone for non-medical indications, such as body building or performance enhancement.
The potential adverse effects of testosterone therapy should be discussed prior to treatment. These include acne, breast swelling or tenderness, increased red blood cell count, swelling of the feet or ankles, reduced testicular size and infertility. Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed.
The optimal follow-up of men on testosterone therapy has not been defined, but should include measurement of testosterone level, PSA (for men of appropriate age) and hematocrit. Other patient-specific measures may be appropriate.
There is a critical need for more federal and industry funding of research to better understand indications, long term benefits and risks of current treatments of hypogonadism, as well as to develop new and improved treatment options.
AUA recognizes and encourages the increased educational awareness of the benefits and risks of testosterone therapy among both patients and healthcare providers. This statement has been endorsed by the American Society for Men's Health, the Sexual Medicine Society of North America and the Society for the Study of Male Reproduction.
Board of Directors, February 2014
Board of Directors, August 2015 (Revised)