FDA Warns Of Dangers From Testosterone Supplements

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FDA Warns Of Dangers From Testosterone Supplements
Photo – WerbeFabrik – pixabay.com

It has been almost a year since the U.S. Food and Drugs Administration (FDA) issued a black box warning against the massive push by drug makers to market testosterone treatments to the average middle-aged American men. The agency highlighted their concern over the potential for testosterone to increase the risk of heart problems. Let’s have a refresher on why the FDA put the brakes on supplemental testosterone and related anabolic-androgenic steroids (AAS), which can cause heart attacks, personality changes, and infertility. [1]

The FDA warned on the possible heart and psychological issues that may occur for millions of American men who use testosterone pills, gels, or receive injections to boost their physical health or libido. The government entity updated the testosterone product labels to clarify the approved use of these medications.

According to the FDA, there are serious safety risks that may affect the heart, brain, liver, and mental health of individuals who take higher doses of testosterone than those typically prescribed by doctors. Athletes and bodybuilders were identified as the main abusers of testosterone and other AAS. [2] Some of the reported serious outcomes are listed below:

• Heart Attack [3]
• Heart Failure
• Stroke [3]
• Depression
• Aggression
• Liver Toxicity [4]
• Male Infertility
• Fatigue
• Loss of Appetite
• Irritability

The advisory was a reminder for doctors to be always on guard for the potential abuse of testosterone. It advised the medical community to measure the patient’s’ blood testosterone levels if they suspect abuse.

Testosterone is the most recognized doping substance used by athletes. [5] The sports community has been beset by many doping scandals involving high-profile personalities. Though strictly prohibited by the World Anti-Doping Agency, the use of performance-enhancing drugs remains blatant. American sprinter Ivory Williams admitted that he used anabolic steroids to enhance his performance. Long jumper Carl Lewis was also found guilty of “inadvertently” using ephedrine, a medication and stimulant that is often found in dietary supplements. [6]

A 2016 study reported that testosterone treatments have no benefits at all on men’s health. This study is an additional blow to the sales of testosterone supplements which reached two billion U.S. dollars annually. It presents data to rebuke the industry’s portrayal of testosterone products as a “miracle drug” for men who want to stop the effects of aging. [7]

Drug companies continue to manufacture testosterone supplements in spite of the availability of evidence on the products’ dangers. Due to a loophole in FDA regulations and the multimillion dollars spent by pharmaceutical firms to market testosterones, doctors continue to prescribe them for off-label use since they are treating based upon symptoms alone. [8]

Back in 2015, the FDA also stressed that approval should be given to prescription testosterone for men who have low testosterone levels caused by certain medical conditions. Men who have low testosterone levels suffer from a condition called hypogonadism due to disorders of the testicles and pituitary gland. [9]

The FDA also urged drug manufacturers to collaborate with the agency on a clinical trial to more clearly address the issue question of whether users of testosterone supplements have an increased risk of heart attack or stroke. It gave the companies permission to work separately if they so choose.

To avoid the risks linked to the use of testosterone supplements, there are natural ways of increasing your testosterone levels. You can consider losing weight, limiting alcohol, reducing stress, and implementing healthy dietary changes before considering testosterone replacement therapy.


[1] U.S. Department of Health and Human Services. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm

[2] ] U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement – Risks Associated With Abuse and Dependence. https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm526151.htm

[3] Vigen R et al. November 6, 2013. Journal of the American Medical Association. Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels. https://jamanetwork.com/journals/jama/fullarticle/1764051

[4] Bassil N et al. June 22, 2009. Therapeutics and Clinical Risk Management. The benefits and risks of testosterone replacement therapy: a review. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701485/

[5] Saudan C et al. July 2006. British Journal of Sports Medicine. Testosterone and doping control. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2657495/

[6] Duncan Mackay. April 24, 2003. The Guardian. Lewis: ‘Who cares I failed drug test?’ https://www.theguardian.com/sport/2003/apr/24/athletics.duncanmackay

[7] Huo S et al. September 21, 2016. Plos One. Treatment of Men for “Low Testosterone”: A Systematic Review. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0162480

[8] Sarita O. Metzger and Arthur L. Burnett. December 2016. Translational Andrology and Urology. Impact of recent FDA ruling on testosterone replacement therapy (TRT). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5182241/

[9] Christina Carnegie. 2004. Reviews in Urology. Diagnosis of Hypogonadism: Clinical Assessments and Laboratory Tests. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1472884/

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