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The treatment of low testosterone (also known as hypogonadism or Low-T) in men has increased significantly since the year 2000. However, with the growth of such testosterone replacement therapy, there has also been an increase in the number of studies that have shown a link to various medical problems, such as the increased risk of heart attacks, strokes and other potentially deadly outcomes.
As a result, the FDA has issued several statements on the use of testosterone therapy, and a number of lawsuits have been filed claiming that treatments to combat low testosterone have resulted in harm to the patient or even fatalities.
FDA Investigates Testosterone Treatments
Although the FDA has not issued any recalls of testosterone due to the possibly dangerous nature of various treatments, early in 2014 the agency published an alert stating that it was going to begin investigating the potentially adverse outcomes of testosterone supplements. Specifically, the FDA denied any conclusions related to increased probability of heart attacks, strokes or death in men undergoing testosterone replacement therapy. However, the agency said that would analyze data from multiple studies and monitor side effects of testosterone treatments as reported through its MedWatch program. The FDA also advised patients and physicians to understand both the risks and the benefits of drugs and supplements before beginning any treatment. 1
In June 2014, the FDA announced that it manufacturers of testosterone would be required to add a warning label to their products indicating the possible formation of blood clots in patients’ veins. The agency stressed that this requirement was unrelated to the separate investigation into the other health problems that may be associated with testosterone use. 2
The FDA has scheduled a multi-committee meeting for mid-September 2014 related to a new oral testosterone tablet. 3