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The FDA is , the agency announced.
In a statement, the FDA said that abuse of testosterone -- "usually at doses higher than those typically prescribed and usually in conjunction with other anabolic androgenic steroids" -- is tied to "serious safety risks affecting the heart, brain, liver, mental health, and endocrine system."
Serious adverse events that have been reported to FDA have included heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility, the agency said.
People who have abused testosterone at high doses have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, FDA said.
FDA is also updating the "abuse and dependence" section of the labels of testosterone and other anabolic androgenic steroids to reflect the adverse outcomes tied to abuse of these drugs, and is updating the "warning and precautions" section to advise prescribers about the "importance of measuring serum testosterone concentration if abuse is suspected."
Last year, FDA forced testosterone drugmakers to change the labeling of their products to reflect that these drugs are meant to be used only in men who have low testosterone for medical reasons such as disorders of the brain, pituitary gland, or testicles, which cause hypogonadism.
The decision followed extensive criticism that the drugs were being doled out to men who didn't have true hypogonadism, but simply lower levels of testosterone due to aging.
It is unclear why the FDA chose to take this action now. In a statement, the agency noted that the Anabolic Steroids Control Act of 1990 placed anabolic steroids, including testosterone, in Schedule III of the Controlled Substances Act.