Testosterone and Anabolic Androgenic Steroids Associated with Adverse Outcomes from Abuse and Dependence
November 11, 2016
FDA approved labeling changes for all testosterone products to warn health care professionals and patients about the risks of abuse and dependence associated with these substances. Case reports and other published data show abuse of prescription testosterone products and anabolic androgenic steroids causes serious adverse side effects. Reported events involve the heart, liver, endocrine system, and brain. High doses of these substances are associated with heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Withdrawal symptoms are also reported (eg, depression, decreased libido, fatigue, irritability, and insomnia).
The new labeling will include a warning to providers about the potential for abuse and dependence associated with testosterone and anabolic androgenic steroids, and the subsequent risk of serious adverse events. The warning will emphasize events related to the heart and mental health. This information will also be added to the Abuse and Dependence section of the label. The Warnings and Precautions section will be updated to encourage prescribers to evaluate blood testosterone concentrations if they suspect abuse. Testosterone and anabolic androgenic steroids are Schedule III (C-III) controlled substances. Prescription testosterone is FDA-approved to treat low testosterone associated with medical conditions (e.g. primary hypogonadism).
- MedWatch Safety Alert – October 25, 2016
- FDA Drug Safety Communication – October 25, 2016
November 11, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.