The Food and Drug Administration (FDA) has approved updated safety label on numerous testosterone replacement therapies to include a new subsection under Warnings and Precautions regarding the risk of abuse. The warning also advises physicians to check serum testosterone concentration in men if testosterone abuse is suspected, to counsel patients of possible serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids (AAS), and to consider the possibility of testosterone and AAS abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
In October, the FDA announced it had ordered the safety label changes to all testosterone replacement treatments and AAS to warn that it was aware of testosterone and AAS abuse 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,” the agency said in a Safety Alert. “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.”
More than 6,000 testosterone lawsuits have been filed against the manufacturers of testosterone treatments alleging the companies aggressively marketed their products but failed to adequately warn of serious risks. The first trials are expected to be heard in the latter half of 2017. The lawsuits name testosterone products including AndroGel, Axiron, and Fortesta.