FDA: Testosterone supplements can cause heart failure, stroke, depression, liver toxicity, insomnia and more

Wednesday, November 09, 2016 by: David Gutierrez, staff writer
Tags: testosterone, FDA, dangers

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(NaturalNews) Testosterone replacement or supplementation products can cause dangerous side effects, including heart attacks, infertility, personality changes and chemical dependency, the FDA has warned.

The agency announced that it is updating the warning labels on all testosterone products.

"The new warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/anabolic androgenic steroid [AAS] abuse," the FDA said.

The FDA drew particular attention to the millions of people who use testosterone therapy off-label, either for body-building uses, or in the hopes of boosting general health or libido. These uses are dangerous and not supported by evidence, the agency warned.

"There's been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone," said Dr. Sidney Wolfe of Public Citizen, when the FDA issued its first warning about off-label testosterone use.

Testosterone and AASs (synthetic forms of the hormone) are FDA approved to treat only certain conditions, such as delayed puberty, muscle loss due to cancer, AIDS or other diseases.

Shrinking testicles and heart attacks

The new labels on testosterone products will add a further warning about the potential for abuse and for serious adverse outcomes, particularly related to cardiovascular and mental health. The existing Warnings and Precautions section will remind prescribers of the importance of measuring circulating blood levels of testosterone in people suspected of abusing the drugs. The Abuse and Dependence section of the label will also be updated to reflect recent research about the risks of testosterone and AAS abuse.

"Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health and endocrine system," the FDA said.

The FDA lists potential side effects, including heart attack, heart failure, stroke, liver toxicity, kidney failure, shrinking testicles, male infertility, baldness, depression, hostility and aggression.

The agency also warns that testosterone abuse can produce chemical dependency (addiction). This produces withdrawal symptoms, including irritability, depression, insomnia, lowered libido, loss of appetite and fatigue.

According to the National Institute on Drug Abuse, "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."

Big Pharma windfall

Last year, the FDA warned that doctors were over-prescribing testosterone for uses that are not supported by evidence. The new warning strengthens this caution, classifying such uses as abuse on par with taking steroids for athletic purposes.

In recent years, Big Pharma has embarked on a massive marketing campaign claiming that a wide variety of vague health problems or age-related complaints are actually caused by low testosterone. Because treating clinically-proven low testosterone is an FDA-approved use, this marketing is legal under U.S. law.

But studies show that among the millions of men taking testosterone pills, gels or injections for "benefits" such as improved alertness, energy, mental sharpness or libido, a quarter were never even given a blood test to establish whether they actually have low testosterone.

The number of men taking testosterone supplements increased 75 percent from 2009 to 2013. The industry now rakes in $2 billion per year.

Even among men who have had their blood tested, testosterone might not be the best choice. Lower than average levels are not necessarily a sign of a health problem. Additionally, hormone supplementation comes with serious risks that may outweigh the benefits – "benefits" that have never been proven in controlled studies.

"Because of the marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs," said Harvard endocrinologist Carl Pallais. "Men should be much more mindful of the possible long-term complications."

Sources for this article include:

MedicalXpress.com

NBCNews.com

FDA.gov

CapitalWired.com

NBCNews.com

Health.Harvard.edu