What is Low-T? Do You Need A Testosterone Supplement? Is There Any Risk?
The above headline comes from a March 3, 2015, article in the Wall Street Journal. This article, as well as several others on this subject, reported on an FDA Drug Safety Communication issued on March 3, 2015, warning about the use of “testosterone products for low testosterone due to aging.”
In the opening of their safety warning, the release states, “The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.”
Recently, pharmaceutical companies have been advertising testosterone drugs for aging men that they have marketed as “Low T.” This advertising is in spite of the fact that it is normal for testosterone levels to fall as men get older.
The FDA warning points out that these drugs were never approved for this type of usage and were strictly intended for medical conditions that create a decrease in testosterone. The report says; “Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.”
The market for selling testosterone prescriptions in the U.S. is very lucrative, with sales exceeding $2 billion in 2013 alone. In the warning, the FDA recognizes that these drugs are being sold for uses not intended. “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”
The Wall Street Journal article points out that the Journal of the American Medical Association published a study in November 2013 showing that men treated with testosterone had a 30% increased risk of death, heart attack, or ischemic stroke compared with those who didn’t take the drug.
In an NPR article on the same day, Dr. Sidney Wolfe, founder of, the Public Citizen’s Health Research Group, criticized the FDA for not issuing a stronger warning sooner. He noted that the Canadian government acted months sooner, thus limiting the amount of testosterone prescriptions and the amount of harm done. He commented, “In the seven and a half months since the Canadian action, approximately 4 million prescriptions have been filled in the U.S.” He continued, “Had the FDA made this announcement last summer when the Canadian government acted, it would have reduced the number of U.S. prescriptions for and damage from testosterone, a medication of questionable effectiveness for a large proportion of users and one that increases the risk of heart attacks and strokes.”.
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