FDA Experts Review Testosterone Therapy Safety Risks

September 17, 2014 — New York Times reports that an advisory panel of experts is meeting today to discuss whether to recommend regulatory action from the U.S. Food and Drug Administration (FDA) to restrict testosterone therapy.

The use of testosterone replacement products has quadrupled since the early 2000s. Testosterone gel products like AndroGel lead the $2 billion/year industry. Over 5 million prescriptions for testosterone products were written in 2011.

The advisory panel will consider what criteria should be used when prescribing testosterone therapy for “age-related hypogonadism” (low testosterone in aging but otherwise healthy men).

According to documents released before the meeting, the experts are not yet convinced that the products increase safety risks. At least three studies have found higher rates of heart attack, stroke, and death, but three other studies found positive benefits or inconclusive results.

The panel is not convinced that testosterone therapy has any benefit for “age-related hypogonadism.” This could have major implications, because recent studies have found that 50% of men on testosterone were never diagnosed with hypogonadism. Up to 25% were given a prescription without a blood test.

With an unclear risk-benefit profile, it is wise for men to exercise caution. During the 1990s, estrogen replacement therapy was aggressively marketed to post-menopausal women. It was promoted as protection against heart disease and as a treatment for hot flashes, low sexual desire, and mood swings. About 20% of women used the drugs when they were at peak popularity.

That all changed in 2002, when a massive study by the Women’s Heath Initiative was halted prematurely after researchers discovered higher rates of blood clots, stroke, and breast cancer, but no protection against heart disease.