The use of prescription testosterone products as hormone replacement therapy is FDA approved for men who have low testosterone due to certain medical conditions. Additionally, there is evidence to suggest that men with depression who use testosterone gel may experience improvements in mood. However, it is well known that testosterone and other AAS are abused by adults and adolescents, including athletes and body builders.
“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system,” according to an FDA statement. “Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.”
According to the FDA, the classwide labeling changes will include additional information about other adverse outcomes associated with abuse and dependence of testosterone/AAS as well as advice to prescribers on the importance of measuring serum testosterone concentration if abuse is suspected.
For related information, see “Large Trial Suggests Testosterone Offers Moderate Benefits.”