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FDA Panel Votes to Restrict Testosterone for Hypogonadism

FDA Panel Votes to Restrict Testosterone for Hypogonadism

September 18, 2014 — An expert panel of advisors to the U.S. Food and Drug Administration (FDA) has overwhelmingly voted in favor of restricting the labels on testosterone treatment products like AndroGel.

The FDA may decide to clarify what diseases the drugs are approved to treat, which would narrow the number of patients drug-makers are allowed to target.

Currently, drug-makers like AbbVie have made billions of dollars mass-marketing testosterone for “Low T.” It has become a catch-all term for age-related symptoms like fatigue, low libido, decreased muscle mass, and depressed mood.

The ads imply that “Low T” is widespread. In reality, hypogonadism is a rare medical condition that is caused by chemotherapy, missing or damaged testicles, brain disorders in the pituitary or hypothalmus, and genetic problems.

Dr. Michael Domanski, one of 20 members on the panel, told the New York Times:

“The whole idea is to try to rein in the inappropriate advertising and use of these drugs.”

All but one member of the panel also voted to recommend additional safety studies. Next year, the National Institute of Health (NIH) will publish the results of a large-scale clinical trial investigating the use of testosterone therapy in men over 65. Unfortunately, the relevance of this study will be limited because only 20% of men on testosterone therapy are over 65.

About 60% of men on testosterone are between the age of 45 and 64. Testosterone levels naturally decline by 1-2% per year after age 40. The benefits of using testosterone for “age-related hypogonadism” are unproven, but at least three studies have found evidence of heart attack, stroke, and other side effects.

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