FDA Orders Safety Labeling Changes on Low-T Products

Turn on any media source these days and you’re bombarded with ads for low-testosterone (“low-T”) products complete with images of the proverbial fountain of youth promising men increased virility, sex drive, attractiveness, and success in business, sports, and life. But the cool, confident voice encouraging you to ask your doctor about these low-T medications fails to mention their potential deadly risks.

In June, the FDA ordered all drug manufacturers of testosterone products to include a general warning about the increased risk of venous blood clots when taking testosterone medication. Venous blood clots can cause tremendous pain such as in the case of deep vein thrombosis in the leg, or possibly a deadly pulmonary embolism where a blood clot breaks off and travels to the lungs.

Low-T products already contained a specific warning about venous blood clots associated with polycythemia, a medical condition that develops when there is an abnormal increase in the number of red blood cells, but the new safety labeling change was prompted after men taking the medication that did not suffer from polycythemia still reported developing venous blood clots.

This is the second time this year the safety of low testosterone medications has been addressed.

In January, the FDA issued a safety alert about the possible cardiovascular effects of low-T medications after two published research reports found an increased risk of heart attacks, strokes, and death in men taking testosterone products.

A Veterans’ Administration study published in November 2013 in the Journal of American Medical Association (JAMA) found a 30% increased risk of cardiovascular events when taking testosterone therapy. And a UCLA study that evaluated more than 55,000 men for the first 90 days after starting testosterone therapy and found more than double the risk of heart attack, stroke, and death in men 65 years old and older. Cardiovascular risk tripled in men under 65 years old who also had a history of heart disease, but found no increased risk in younger men with a negative cardiac history.

The FDA is still evaluating the effects of low-T meds on men’s arterial health and has not commented on the cardiac risks since issuing a safety alert in January. There currently is no warning on low-T medications about an increased risk of a heart attack.

Testosterone is a hormone essential to the development of male characteristics. Testosterone replacement drugs are FDA-approved only to treat men suffering from low testosterone caused by an underlying medical condition. It is not FDA-approved for men who do not have an associated medical condition causing low testosterone levels but sales of low-T medications have soared due to aggressive marketing by the pharmaceutical manufacturers for everything from decreased energy and fatigue to a decreased libido and low sex drive.

Taking these meds is not a casual decision as there are very real life side effects. Cardiologist Dr. Steve Nissen of the Cleveland Clinic warned, “What’s going on is a giant experiment with American men’s health at stake because we don’t have the long-term data on the safety of these products.”

While we’re all waiting for the FDA to conclude its safety re-investigation on low-T products and their effects on the arteries, it may be a good time to discuss with your doctor the risk and benefits of taking a low testosterone product, to re-evaluate whether the medication is right for you, and to consider other alternatives that don’t present an unacceptable risk.

If you have any kind of adverse reaction to a testosterone product, please report it to the FDA’s MedWatch Safety Information and Adverse

Reporting system at https://www.accessdata.fda.gov/scripts/medwatch/. The database of complaints and symptoms help the FDA determine if the product is negatively affecting users, whether to include additional warnings or to withdraw FDA approval and remove the product from the market.