FDA Approves Warning Label Changes for Testosterone and Other Anabolic Androgenic Steroids

The FDA has approved class-wide labeling changes for prescription testosterone products regarding risks of abuse and dependence associated with testosterone and other anabolic androgenic steroids (AASs).

The labeling changes include adding a new Warning and updating the Abuse and Dependence section with new safety information conceived from published literature. The revised Warning will alert prescribers to the adverse effects, especially those related to heart and mental health, of prescription testosterone products, as well as the potential of abuse and dependence risk in patients.

Additionally, in the Abuse and Dependence section, all testosterone labeling has been updated to include information about adverse outcomes reported in association with abuse and dependence. Further information in the Warning and Precautions section will alert prescribers about the importance of measuring serum testosterone concentration if abuse is suspected.

Prescription testosterone products are commonly used as hormone replacement therapies for men with low testosterone due to medical conditions. Testosterone and other AASs are often abused by adults and adolescents, especially athletes, despite the serious safety risks.

AASs, including testosterone, were placed in Schedule 3 of the Controlled Substances Act under the Anabolic Steroids Control Act of 1990. Reported adverse effects include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.