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FDA: Testosterone Therapy May Increase CV Risk

According to the FDA, men who use testosterone therapy to remedy low testosterone could be at a heightened risk for adverse cardiovascular events including heart attack, stroke, and death. For this reason, the FDA will now require testosterone products to include risk warnings and specify the approved uses of those products on their labels.

The FDA recommended the following for healthcare providers and patients:

  • Healthcare professionals should treat men with testosterone therapy if they have low levels due to specific medical conditions that were confirmed by laboratory testing.
  • Healthcare professionals should warn patients of potential increase in cardiovascular risk before starting or continuing testosterone therapy.
  • Patients using testosterone therapy should seek immediate medical attention if they experience heart attack or stroke symptoms including shortness of breath, difficulty breathing, chest pain, weakness in 1 side of the body, or slurred speech.

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“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 hypogonadism,” they wrote.

“However, 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,” they said.

The complete recommendations are published on the FDA’s website.

-Michelle Canales Butcher

Reference:

1. US Food and Drug Administration. Testosterone products: 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. March 3, 2015. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436280.htm?source=govdelivery&utm_medium=email&utm_source=govdeliver. Accessed March 4, 2015.