FDA Panel Wants Tighter Labels on Testosterone Drugs

FDA Panel Wants Tighter Labels on Testosterone DrugsSeptember 18, 2014 — An advisory panel of experts recommended restricting the use of testosterone therapy to men who have been diagnosed with hypogonadism.

The panel also voted to recommend more studies to investigate risks. The National Institute of Health (NIH) is currently conducting a large-scale study, but it only involves men over 65 years old. Only about 20% of men on testosterone therapy are over 65.

The New York Times talked to Dr. Michael Domanski, a member of the panel who said, “The whole idea is to try to rein in the inappropriate advertising and use of these drugs.”

Recent studies indicate that only about half of men on testosterone have actually been diagnosed with hypogonadism, and 20-25% received a prescription without ever having a blood test. Today, millions of men are on the drugs. The number of prescriptions has jumped 65% in the last five years.

The success is largely due to easy-to-use gel products like AndroGel, which are advertised for the treatment of “Low T.” Many men view the drugs as a “fountain of youth” to cure fatigue, low libido, depressed mood, and decreased muscle mass.

The FDA is concerned that the benefits of using testosterone for “age-related hypogonadism” are unproven, and the risks may include life-threatening heart attacks and strokes.

Testosterone levels naturally decline by 1-2% per year after age 40. True hypogonadism is caused by a medical condition, such as chemotherapy, genetic testicular disorders, missing or damaged testicles, brain disorders (pituitary or hypothalmus), and more.

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