Taylor Hooton Foundation > Hoot’s Corner > General > FDA adds new warning, updated labeling for T products
November 8, 2016
FDA adds new warning, updated labeling for T products

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The FDA has announced that it added a new warning and has updated labeling for all prescription testosterone drugs. The changes reflect published research on risks associated with abuse and dependence of testosterone and other anabolic-androgenic steroids, according to an FDA announcement.

The new warning information is meant to alert prescribers about potential abuse associated with testosterone drugs.

Adolescent and adult athletes and bodybuilders are among those known to abuse testosterone and other anabolic-androgenic steroids. Testosterone abuse usually occurs in conjunction with use of other anabolic-androgenic steroids, when individuals might be taking higher testosterone doses than are generally prescribed. Abuse of the drug or drugs can lead to heart, brain, liver, mental health, and endocrine system problems.

“Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia,” according to the FDA.

The FDA has also approved information related to testosterone drug labeling in the drugs’ Warning and Precautions section, advising prescribers of how important it is to measure serum testosterone concentration when they suspect abuse.

Urology Times Editorial Council member James M. Hotaling, MD, MS, of the Center for Reconstructive Urology and Men’s Health, University of Utah, Salt Lake City, says that he and his colleagues see a significant number of patients who have previously been on anabolic-androgenic steroids.

“I would say these patients constitute 5% to 7% of our hypogonadism practice at the University of Utah Men’s Health Center,” Dr. Hotaling said. “Typically, these men either have been on or are on massive amounts of [intramuscular] testosterone (1,000 mg or more per week), methandrostenolone, human growth hormone, human chorionic gonadotropin (hCG), clomiphene (Clomid), and/or 4-chlorodehydromethyltestosterone.”

Almost all of those men get access to the drugs through people at their gyms who are known to dispense them, according to Dr. Hotaling.

“Most… attempt to build muscle; some to improve symptoms of hypogonadism,” Dr. Hotaling said. “The men even sometimes find another doctor to check some of their laboratory work and often come in asking us to manage their labs, while they remain on anabolic steroids—a practice which we strictly avoid per our policy.”