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FDA to Review Benefits and Risks of Testosterone Therapy


September 12, 2014 — There is little evidence of any benefit from testosterone therapy in aging men who do not have hypogonadism, but the safety risks are also unclear.

The U.S. Food and Drug Administration (FDA) published those conclusions in a report (PDF) ahead of an advisory panel meeting on September 17.

According to the agency:

“Treatment benefits with TRT for ‘age-related hypogonadism’ remain questionable, and there are no reliable data on the benefit in such a population.”

The FDA is also unsure of the risks. Citing five studies, two of which found evidence of cardiovascular side effects, the FDA concluded: “These studies do not provide conclusive evidence of increased cardiovascular risk associated with testosterone therapy.”

The two studies were published in November 2013 and early 2014. One study found evidence of a 30% increased risk of heart attack, stroke, and death. The other study found a doubled risk of heart attack among older men. However, the studies were limited by small sample sizes, short duration of the study, and other factors.

The FDA believes it is important to review the safety of testosterone because it has skyrocketed in popularity. Sales jumped 65% n the last five years and by 2013, 2.3 million patients received a prescription for testosterone.

Studies indicate that only about half of patients have actually been diagnosed with hypogonadism, the only medical condition testosterone therapy is approved to treat. About 25% received a prescription without ever having a blood test to check testosterone levels.

The problem is that symptoms of hypogonadism overlap with many of the normal side effects of aging — low energy levels, sexual dysfunction, decreased muscle mass, bone loss, and increased fat. The use of testosterone therapy to treat these symptoms remains controversial.


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