The new study was published in Scientific Reports (4/20/16). In it, researchers note that vascular calcification is a strong predictor of cardiovascular disease. The higher the calcification levels, the greater the risk of death from cardiovascular problems. Men have a higher risk of cardiovascular disease, suggesting to researchers that testosterone might play a role in influencing calcification.
Calcification is an increase in the level of calcium in the blood. A buildup of calcium can cause soft tissues - including cardiac muscle, heart valves and arteries - to harden or narrow, resulting in reduced or restricted blood flow. This, in turn, can result in life-threatening cardiovascular problems.
For the study, researchers examined mice to analyze the role of testosterone in blood tissues. What they found suggested that testosterone could trigger calcium to build up in soft tissues, resulting in calcification. Researchers noted a “potential link between pharmacological androgen use and vascular calcification.”
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As a result, the FDA required all prescription testosterone products to change their label to reflect the possibility of an increased risk of heart attacks and strokes. Companies that manufacture testosterone products were also required to conduct adequate clinical trials to address the issue of increased risks of heart attack or stroke.
Lawsuits have been filed by men alleging they were prescribed testosterone therapy but were not warned about the potential for permanent, serious side effects. Some lawsuits further allege testosterone therapy was prescribed to treat a medical condition called “Low-T,” which was not actually a medical condition but was, instead, a normal part of aging.