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Regulatory Focus™ > News Articles > FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone

FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone

Posted 25 October 2016 | By Zachary Brennan 

FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone

The new labels for all prescription testosterone products include a new warning and an updated Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). 

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are approved for use in men who lack or have low testosterone levels, including for conditions such as a failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.

The label changes announced on Tuesday by the US Food and Drug Administration (FDA) follows the placement of AAS, including testosterone, in Schedule III of the Controlled Substances Act thanks to the Anabolic Steroids Control Act of 1990.

“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,” FDA said.

Reported adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity and male infertility. The agency noted that individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido and insomnia. 

Due to these reports, the new label’s warning will alert prescribers to the abuse potential of testosterone and the adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse.

In addition to the new warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.     

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence


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