FDA Adds New Warning to Testosterone Label

The FDA has approved class-wide labeling changes for all prescription testosterone products including a new Warning and updating the Abuse and Dependence section with information regarding the risks of abuse and dependence of testosterone and other anabolic androgenic steroids (AAS).

The abuse of testosterone, the FDA noted, is associated with serious risk to the heart, brain, liver, and endocrine system.
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The new Warning alerts prescribers to the risk of abuse and the adverse outcomes associated with abuse. All labeling will also include new information in the Abuse and Dependence section on the adverse outcomes, and information in the Precautions section regarding the importance of measuring serum testosterone concentrations if abuse is suspected.

—Michael Potts

Reference:

FDA. Testosterone and other anabolic androgenic steroids (AAS): fda statement - risks associated with abuse and dependence. October 25, 2016. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526151.htm. Accessed October 26, 2016.