Fewer men using testosterone therapy following FDA warnings

Low T1 Fewer men using testosterone therapy following FDA warningsFewer men in the United States are using testosterone replacement therapy following a stark decrease from 2013 to 2016 over concerns with over-prescribing and health risks, according to researchers with the University of Texas Medical Branch at Galveston.

Testosterone treatments, including AbbVie’s Androgel, were heavily touted by drug companies as cure-alls for so-called Low T, a contrived condition caused by an age-related drop in testosterone levels that leads to symptoms such as low sex drive, weight gain, muscle loss and fatigue. The ad campaign resulted in hundreds of thousands of prescriptions for the male hormone supplement.

Testosterone replacement therapies are only indicated for hypogonadism, a condition in which men do not produce enough testosterone due to defect or injury. It is not intended for men with a natural age-related drop in testosterone.

Studies began to raise serious questions about the use of testosterone therapy, suggesting that the treatments could increase cardiovascular risks such as heart attacks, strokes, and blood clots. In March 2015, the Food and Drug Administration (FDA) cautioned the public about its safety concerns with the use of testosterone treatments for age-related drops in testosterone and required manufacturers of testosterone products to change the labeling on the products to clarify the approved uses of the medications.

The agency also required all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with use.

Following the FDA’s warning, the researchers found that the number of men prescribed testosterone declined by 48 percent following a six-fold increase during the prior decade, as well as a 62 percent decrease in new testosterone users.

Dr. Shalender Basin, an endocrinologist with Brigham and Women’s Hospital in Boston, said the decrease in testosterone use is “definitely a good thing. It’s a hopeful sign that educational efforts in science do matter, and people pay attention to both the science and information from clinical studies that’s being put out by scientists.”

FDA Safety Communication