FDA to Probe Testosterone Therapy Claims, Safety

By Dennis Thompson HealthDay Reporter

TUESDAY, Sept. 16, 2014 (HealthDay News) -- The U.S. Food and Drug Administration is focusing on the "Low T" fad, questioning whether the boom in testosterone replacement therapy is helping or harming the health of aging American males.

At a joint meeting scheduled for Sept. 17-18, two key FDA committees will discuss whether doctors are prescribing testosterone therapy for too many men, and if misuse of the male hormone increases the risk of stroke and heart attack.

The Baby Boom generation has turned to testosterone replacement therapy in response to the sagging muscles, lower energy levels and sexual problems that can 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," said Dr. Bradley Anawalt, an endocrinologist from the University of Washington in Seattle.

However, 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.

At the joint FDA committee meeting in Hyattsville, Md., the panelists will be asked to vote on two key issues: Whether the agency should revise current indication for testosterone therapies, and whether sponsors of testosterone products should conduct studies to further assess a potential cardiovascular risk.

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

"This is a hormone that has been used as a therapy for decades without much scrutiny," he added.

The number of patients with a testosterone prescription nearly doubled over three years, leaping from 1.3 million people in 2010 to 2.3 million in 2013, according to the FDA review, done by Dr. Christine Nguyen, the agency's deputy director for safety, and Dr. Hylton Joffee, director of the FDA's division of bone, reproductive and urologic products.

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FDA to Probe Testosterone Therapy Claims, Safety