FDA adds new warning, updated labeling for T products

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.”

Also see: Testosterone solution yields improved sex drive, energy

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.”

Next: "We all must be aware of the role and impact of [anabolic-androgenic steroid] use in our patient population.”

While the labeling changes are aimed at educating prescribers, Dr. Hotaling says that urologists are probably already more educated on the effects and side effects of these drugs than any other medical specialty.

Read - Hypogonadism: Expert panel adopts nine resolutions

“We often are the physicians who these patients seek when they have infertility or other health-related issues arising from cycling on or off these drugs,” Dr. Hotaling said. “I am not aware of any urologists who would prescribe unsafe levels of hCG, Clomid, or testosterone, but we all must be aware of the role and impact of [anabolic-androgenic steroid] use in our patient population.”

Urologists, he says, should counsel these patients about needed lab tests and safe alternatives to anabolic-androgenic steroid use, as well as the necessity of monitoring men once urologists convince them to stop taking anabolic-androgenic steroids. The message should be that most of these patients will need long-term hormone therapy managed by a urologist, according to Dr. Hotaling.

Patients know that obtaining anabolic-androgenic steroids from a friend at the gym and starting on a cycle of these drugs fueled by their desire to build muscle is unsafe, Dr. Hotaling says.

“If I am going to work with these patients, I insist that I be the only one prescribing them testosterone, and that we will maintain their levels in a safe range,” he said. “Due to this [approach], they will likely lose some muscle mass and may not have as much energy as when they were using anabolic-androgenic steroids.”

It’s important that urologists provide care for these patients. Low-T mills are ill-equipped to handle the complex endocrine management required when men transition off anabolic-androgenic steroids and do not have the full screening armamentarium necessary for these patients, such as the ability to perform prostate biopsies, according to Dr. Hotaling.

In the end, it should be the urologist who strikes the balance between helping patients feel better and avoid abuse. Urologists can decide at what upper testosterone limits they feel comfortable maintaining patients.

“For us, [that comfortable limit] is 1,000 ng/dL,” Dr. Hotaling said.

Urologists should also counsel patients that it is difficult-often impossible-to fully replicate the energy and muscle mass enjoyed by many men who have testosterone levels in the 2,000 ng/dL to 4,000 ng/dL range.

“Being honest and letting these men know that they are significantly improving their health and longevity [by] coming off these drugs is critical, as is offering safe alternatives that will prop up a hypogonadal axis that has long been suppressed by anabolic-androgenic steroids,” he said.

Dr. Hotaling owns equity in the startup companies Nanonc, StreamDx, and Andro360.

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