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FDA Testosterone Panel Recommendations

Published on Oct 1, 2014 at 11:20 am in Testosterone Therapy.

A Food & Drug Administration advisory panel on the use of testosterone therapy recently made two primary recommendations. Bloomberg.com reports that the panel voted 20-1 during its September 17 meeting to:

(1) Tighten use of the therapy treatments. The panel recommended that the FDA should require language on the product labels clarifying that their use is restricted to only the intended uses of the drugs.

(2) Require the drug makers to study the possible increased risk the drug poses for heart attack and stroke.

The panel was a joint meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The meeting was convened to address:

  • The appropriate indicated population for testosterone replacement therapy, and
  • The potential for adverse cardiovascular outcomes associated with its use.

The main issue has arisen because testosterone therapies are widely prescribed for men who are simply suffering the effects of aging, which include lower sex drives and energy levels.

WebMD reports that an analysis by the FDA uncovered that only half of the men currently prescribed testosterone therapy were actually diagnosed with hypogonadism. Hypogonadism is the specific medical diagnosis for testosterone deficiency approved for the testosterone replacement therapy.

The FDA raised concerns earlier this year when it announced it was looking into studies showing a possibility of increased risk of heart attack, stroke, or death for men using the testosterone therapies.

The FDA Advisory Panel agreed there is little evidence that the testosterone drugs are effective in treating symptoms of aging.

“The whole idea is to try to reign in the inappropriate advertising and use of these drugs,” panel member Dr. Michael Domanski told The New York Times. Domanski directs heart failure research at New York City’s Mount Sinai School of Medicine.

The FDA does not have to follow its advisory committee’s recommendations, however, it usually does. Currently, the National Institutes of Health is sponsoring a trial investigating whether the benefits of testosterone replacement therapy in older men primarily outweigh any risks of heart disease or other side effects.