FDA Approves new Testosterone Supplement/Therapy Labels, Warning of Abuse

Several million men in America currently use testosterone pills (or gels or get injections) as a means to boost their physical health or their libido. Anabolic steroids, of course, are synthetic variations of natural testosterone, and can be legally prescribed to treat several conditions including delayed puberty and other diseases like AIDS and cancer—which can cause muscle loss.

However, the FDA warns that “testosterone and other AAS are abused by adults and adolescents, including athletes and body builders,” and this abuse is typically at much higher than those typically prescribed for simple interventions. Furthermore, this abuse has been linked with severe safety risks “affecting the heart, brain, liver, mental health, and endocrine.”

Even the National Institute on Drug Abuse shares that “some athletes and bodybuilders abuse these drugs to boost performance or improve their physical appearance.” The agency goes on to warn, additionally, “Long-term steroid abuse can act on some of the same brain pathways and chemicals — including dopamine, serotonin and opioid systems — that are affected by other drugs. This may result in a significant effect on mood and behavior.”
They also warn that long-term abuse of anabolic steroids can cause an extremely range of health effects. This can include: baldness, kidney failure, and even shrinking of the testicles.

In addition, the agency has also reported “serious adverse outcomes” that might include: aggression, depression, heart attack, heart failure, hostility, and stroke, as well as liver toxicity and even male infertility. Those who abuse testosterone at very high doses have also reported withdrawal symptoms. These include: depression, insomnia, fatigue, irritability, decreased libido, and loss of appetite.

As such, the FDA will now issue a warning that will alert prescribers of the potential abuse for testosterone products and the serious risks—and particularly those risks associated with either heart and/or mental health. Additionally, the new warning will add revised information in the Abuse and Dependence section describing adverse outcomes that have been reported in association with the abuse and dependence of testosterone or anabolic androgenic steroids. They will also include new safety information on case reports and published literature.

Finally, they will include new information in the Warning and Precautions section that advises prescribers to measure serum testosterone concentration if they suspect abuse.

It is also important to note, however, that the FDA has not approved the use of testosterone to treat aging (or the effects, thereof).

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