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New FDA Testosterone Labeling Rules: What Should Men Know?

Have you heard the latest on testosterone?

On October 25, 2016, the U.S. Food and Drug Administration (FDA) announced new rules regarding the labeling of testosterone products. Manufacturers must now warn consumers about the risk of abuse. (See the SexHealthMatters summary here.)

Testosterone has a number of medical benefits, which we’ll discuss more below. However, some men take more than they need. Or they take it with androgenic anabolic steroids - drugs based on testosterone or a synthetic version of it. For example, some athletes and bodybuilders take these drugs to build up their muscles and give them more strength.

The FDA has concerns about the effects of testosterone abuse, which can include heart, brain, and liver damage. Abuse can also lead to problems with a man’s endocrine (hormonal) system and mental health.

In a statement, the FDA explained that men who abuse testosterone are at risk for “heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.” Testosterone withdrawal can have side effects also, such as fatigue, insomnia, appetite loss, and decreased sex drive.

What does all this mean? Is it still safe to take testosterone? Today, we’ll go over some of the basics and put the new FDA warnings into perspective.

What is testosterone?

Testosterone is a male sex hormone, one that is inextricably linked to masculine characteristics. Think about the changes a boy undergoes during puberty. His penis grows larger. His voice deepens. He becomes more muscular. He develops facial hair and pubic hair. Testosterone is responsible for all these changes. It maintains those characteristics in adulthood, too.

Testosterone is also important for sexual function. It drives a man’s libido and plays a role in his erections.

Why might men need to take testosterone?

Sometimes, men’s bodies do not produce enough testosterone on their own. Certain congenital conditions (present at birth) can affect testosterone production. So can cancer treatments like chemotherapy or radiation, along with genital injuries. The FDA has approved the use of testosterone for situations like these.

Men’s testosterone levels decline as they get older, too. This is called adult-onset hypogonadism and it’s a natural part of aging. Men may start to feel weak, fatigued, and less interested in sex when this happens. Sometimes, men can boost their testosterone by making healthy lifestyle choices, like losing weight or keeping their blood sugar under control if they have diabetes. Doctors may also prescribe testosterone therapy, although this use has not been approved by the FDA.

Should men worry about the new FDA rules?

Remember, the new FDA warnings concern testosterone abuse. If you feel that you are abusing testosterone or anabolic steroids, absolutely see your doctor. Otherwise, you can probably continue taking testosterone, as long as you do so responsibly and sensibly, under a doctor’s care.

Here are some other things to keep in mind:

·         Take testosterone as directed. If your doctor has prescribed testosterone for you, take it exactly as directed. If you feel your testosterone therapy isn’t working as you’d hoped, talk to your doctor. You may need to make some adjustments, but this should only be done with a doctor’s advice. Do not raise or lower your dose on your own.

·         Do not buy testosterone online or over the counter. Testosterone should be obtained only by prescription. Supplements may contain ingredients you’re not aware of and these could have dangerous side effects. (Clickhere to learn more about the dangers of non-prescription testosterone and similar products.)

·         Don’t hesitate to ask questions. If you have questions about testosterone and whether it’s right for you, see your healthcare provider. Your doctor can measure your testosterone levels to see where you stand. He or she can also give you a full medical checkup to determine whether other medical conditions are contributing to low testosterone symptoms. Overall, it’s best to get the whole picture.


Hormone Health Network

“What Does Testosterone Do?”

(January 2014)

Rettner, Rachel

“Prescription Testosterone Gets New Warning”

(October 25, 2016)

MD Magazine

Black, Ryan

“FDA Announces Stern New Warning Labels for Testosterone Treatments”

(October 25, 2016)


Brooks, Megan

“FDA Adds New Warnings to All Testosterone Product Labels”

(October 25, 2016)


Clarke, Toni

“U.S. FDA adds abuse warning to prescription testosterone”

(October 25, 2016)

Sexual Medicine Society of North America

“New Research on Adult-Onset Hypogonadism Provides ‘Conceptual Framework’”

(June 21, 2016)

“Performance-Enhancing Drugs and Sexual Health”

“Risks and Realities of OTC Testosterone Supplements”

(April 9, 2013)

U.S. Food and Drug Administration

“FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)”

(Press statement. October 25, 2016)