FDA Adds New Warning to All Testosterone Replacement Products

The new Warning alerts prescribers to the abuse potential of testosterone
The new Warning alerts prescribers to the abuse potential of testosterone

The Food and Drug Administration (FDA) has approved a class-wide labeling update for all prescription testosterone products, which includes a new Warning and an updated Abuse and Dependence section.

Testosterone products are prescribed for use as hormone replacement therapy in men who have low testosterone levels due to certain medical conditions. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. 

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Testosterone and other anabolic androgenic steroids (AAS) are often abused by adolescents and adults, including athletes and body builders; in 1990, the Anabolic Steroids Control Act placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Abuse of these products at higher-than-prescribed doses has been linked to serious safety risks that affect the brain, liver, heart, psychiatric and endocrine systems. Serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Reported withdrawal symptoms include depression, fatigue, irritability loss of appetite, decreased libido, and insomnia.  

A new Warning added to the labeling alerts prescribers to the abuse potential of testosterone and its serious adverse outcomes—particularly cardiovascular and psychiatric-related effects that have been associated with testosterone/AAS abuse. The update also advises prescribers of the importance of measuring serum testosterone levels if abuse is suspected.

The Abuse and Dependence section now includes information about adverse outcomes associated with abuse and dependence of these products. 

Healthcare professionals and patients are encouraged to report any adverse reactions with the use of testosterone products to the FDA's MedWatch Adverse Event Reporting Program.

For more information visit FDA.gov.

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