FDA Issues New Warning on Testosterone Therapy Medication

The Food and Drug Administration (FDA) announced on March 3rd that it will require pharmaceutical companies that produce testosterone replacement therapy (TRT) medication to include warning labels on their products regarding the potential risk for heart attack and stroke.

ABC affiliate KVUE News reports that the FDA is concerned that the popular and controversial treatment for low testosterone in men can increase the risk of heart attack, stroke, and other cardiovascular problems. Its warning comes after a 2014 study that suggests TRT doubled the risk of heart attack for men over 65, and tripled the risk for younger men with pre-existing heart conditions.

Not all in the medical field agree with the FDA’s assessment, however. Dr. Paul Pagley, a cardiologist at the Heart Hospital of Austin and Austin Heart, considers the FDA’s demand for a warning label to be dubious, as there are several other studies that come to the opposite conclusion — that TRT doesn’t increase risk at all.

“It’s a little bit of a controversial topic right now,” Pagley said. “There may be some increased risk of heart attack or other heart problems with testosterone supplementations. On the other side of the fence, testosterone has a lot of good effects for men with true low T.”

Patients with “low T” (as low testosterone, or hypogonadism, is commonly shortened to) are actually exempt from the FDA’s warning as TRT does improve such patients. However, the risk for cardiovascular illnesses increases for those who do not have low T, but who simply take it in an attempt to increase strength and stamina.

“To use testosterone, it should be a definite requirement,” Pagley said. “In other words, it’s truly for men with true low testosterone. It should not be used in a situation just to feel better or stronger.”

In addition, the Seattle Times reports that men taking cholesterol medicine such as pitavastatin (Livalo), atorvastatin (Lipitor), and simvastatin (Zocor) are also at risk of having the testosterone levels drop, so they are cautioned about taking TRT medicine.

Low testosterone can be tricky to diagnose. The male body’s testosterone levels naturally peak around 30 years of age and subsequently decreases by 1-2% every year. Some patients initially feel that their symptoms are mere signs of aging. Men who suspect they have low testosterone should seek out medical testing immediately.

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