FDA panel: limit testosterone drug use

By Dennis Thompson HealthDay Reporter

THURSDAY, Sept. 18, 2014 (HealthDay News) -- There is little evidence that testosterone replacement therapy effectively treats normally sagging levels of the hormone in aging American males, a U.S. Food and Drug Administration advisory panel said Wednesday.

The panel, from two key FDA committees, overwhelmingly voted, 20-1, to tighten use of the popular drugs and require drug makers to conduct tests assessing the drugs' risk of heart attack and stroke, according to Bloomberg News.

"The whole idea is to try to rein in the inappropriate advertising and use of these drugs," Dr. Michael Domanski, a panel member who is director of heart failure research at Mount Sinai School of Medicine in New York City, told The New York Times.

The FDA is not required to follow the recommendations of its expert panels, but usually does.

Along with sharply curtailing how many men might be prescribed testosterone supplements, insurance companies could also limit coverage for their use if the FDA follows its panel's advice, experts told the Times.

In what has become known as the Low-T fad, Baby Boom generation men have turned to testosterone replacement therapy in response to the sagging muscles, lower energy levels and sexual problems that often accompany natural aging, the FDA noted in a review provided to committee members in advance of the meeting.

"There's a large group of men out there who are getting older, and they are looking for ways to evade the consequences of aging," Dr. Bradley Anawalt, an endocrinologist from the University of Washington in Seattle, said ahead of the meeting.

The FDA review pointed out there's no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging. Yet the "Low-T" craze has been aided by consumer advertising for remedies that promise renewed vitality and strength for aging men, the report said. It also noted that there's growing evidence many men who are receiving testosterone replacement therapy do not need it.

Anawalt said he hoped the FDA hearing signals increased government oversight of testosterone therapy and increased public funding for studies on its effectiveness.

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FDA panel: limit testosterone drug use