FDA Panel Reviews Safety of Testosterone TherapySeptember 17, 2014 — An expert panel to the U.S. Food and Drug Administration (FDA) is considering whether to take regulatory action regarding the use of testosterone replacement products, according to the New York Times.

With millions of men on testosterone products like AndroGel, the panel’s decisions could have major implications. They are deciding what criteria should be used to prescribe testosterone in aging men who are otherwise healthy except for low testosterone levels. They are also evaluating evidence of safety risks, such as heart attack and stroke.

The panel released documents last week indicating that experts believe evidence of safety risks is inconclusive. However, there is also little evidence of any benefit for using testosterone to treat “age-related hypogonadism.” Testosterone levels naturally decline in aging men, resulting in symptoms like fatigue, sexual dysfunction, loss of muscle mass, and more.

The $2 billion per year industry has popped up amid pervasive advertisements aimed at convincing middle-aged men that they might have “Low T” if they experience common side effects of aging. Recent studies indicate that only 50% of men on testosterone therapy have actually been diagnosed with hypogonadism. About 20-25% received a prescription without ever having a blood test to check testosterone levels.

The skyrocketing popularity of testosterone therapy is a déjà vu moment for some doctors. In the 1990s, hormone replacement therapy was aggressively marketed to post-menopausal women as a treatment for hot flashes, mood swings, and low libido. At peak popularity, 20% of post-menopausal women were on the drugs.

That changed in 2002, after a study by the Women’s Health Initiative discovered that hormone therapy increased the risk of blood clots, stroke, and breast cancer, and did not protect against heart disease.

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