FDA Finds Little Benefit for Testosterone TherapySeptember 12, 2014 — The U.S. Food and Drug Administration (FDA) says there is little evidence that testosterone therapy is beneficial. However, the FDA also believes evidence of cardiovascular risks is still inconclusive.

The agency posted a report (PDF) ahead of an advisory panel meeting scheduled to begin on September 17.

The FDA is not convinced that everyone on testosterone therapy actually needs the medication:

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

Health experts also plan to discuss two recent studies linking the use of testosterone with a higher risk of heart attack, stroke, and death. One study of male veterans between 2005-2011 found a 30% increased risk of cardiovascular events. The other study found an increased risk of heart attacks for older men in poor health who took testosterone.

However, the FDA is not convinced that testosterone therapy is risky. After reviewing the studies, the agency concluded:

“These studies do not provide conclusive evidence of increased cardiovascular risk associated with testosterone therapy.”

In the last five years (2009-2013), sales of testosterone drugs have increased 65%, with 2.3 million patients receiving a prescription in 2013. The largest group of patients is men aged 40-60 years old.

Studies indicate that only half of these men have been diagnosed with hypogonadism and 25% did not have blood tests before receiving a prescription. Many of these men have low testosterone simply because they are aging.

Unfortunately, symptoms of aging overlap with hypogonadism — decreases in energy level, sexual dysfunction, bone loss, decreased muscle mass and strength, and increases in fat. Whether these symptoms are a consequence of low testosterone or the natural aging process is unknown, and therefore the need to replace testosterone is controversial.

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