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.
"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.
An FDA analysis found that only about one-half of men now taking testosterone therapy have been diagnosed with hypogonadism, the specific medical diagnosis for testosterone deficiency.
Further, 25 percent of men started the therapy without lab testing to confirm that they had low levels of testosterone, the report said. More than one in four never received a lab test during the course of their therapy, which is crucial to making sure the patient's hormone levels are within the normal range, according to the FDA.
"Many endocrinologists feel that testosterone is being prescribed for men without a clear indication for its use, or for men who are not indicated for it at all," said Anawalt.
Testosterone therapy, even if used correctly, could have serious consequences for heart health, the FDA report added.
One recent study found a 30 percent increased risk of stroke or heart attack in a group of men recently prescribed testosterone therapy, the FDA said. Another found that men 65 and older experienced a two-fold increase in heart attack risk within the first three months of receiving a testosterone prescription, according to the agency.
In June, the FDA announced that testosterone supplement products must now carry a warning label on the general risk of blood clots in the veins.
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