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FDA: ‘Low T’ Therapy Has Yet to Be Proven
Despite rampant direct-to-consumer ads regarding “low T” in older men, the FDA has concluded that the available evidence does not support an indication for testosterone therapy for age-related hypogonadism.
Writing in the August 20 edition of the New England Journal of Medicine, FDA officials said that only controlled clinical trials can show whether men benefit from treatment to reverse age-related dips in testosterone. The agency is now requiring product manufacturers to conduct such trials.
Currently, testosterone supplements are approved only for men with certain medical conditions that cause abnormally low levels of the hormone, such as damage to brain areas that control testosterone production. But once the FDA approves a drug, doctors are free to prescribe it “off label” as they see fit. Most American men receiving testosterone therapy have no clear medical condition; rather, they’re using it to counter the aging process, according to the authors.
Between 2009 and 2013, the number of U.S. men treated with testosterone increased from 1.3 million to 2.3 million, according to the FDA. The most common reason for testosterone therapy, the agency says, is the vague diagnosis of “testicular hypofunction, not elsewhere classified.”
The dramatic rise in testosterone use has occurred despite a lack of evidence showing that it is effective, the new report says. The surge has been attributed to an aggressive marketing campaign by manufacturers alerting men to the potential effects of “low T,” such as fatigue, sexual dysfunction, declining muscle mass, and gains in body fat.
“The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone,” said lead author Dr. Christine Nguyen.
Typically, a man’s testosterone levels slowly decline with age, and there is a “rough correlation” between that decline and symptoms, such as sexual dysfunction, according to Dr. Bradley Anawalt, an endocrinologist and professor of medicine at the University of Washington in Seattle. But it’s not clear whether “low T” or other factors — such as chronic health conditions, medications, or the aging process itself — are to blame. And it’s unlikely, Anawalt said, that men with modestly low testosterone levels would derive any benefit from testosterone supplements.
In addition, concerns persist that supplements increase a man’s risk of heart attack or stroke. Last March, the FDA started requiring all prescription testosterone products to carry a warning about those potential hazards.
FDA research has found that many men do not have testosterone testing done before getting a prescription for supplements.
Anawalt said that for men with medical conditions that limit testosterone production, it’s “pretty clear” that supplements can be helpful. “The question remains,” he said, “what do you do with the much larger group of men who have ‘low T’ related to aging?"
Based on what’s known, Anawalt said, supplements are “unlikely to do much” for most men whose testosterone levels have dipped solely because of age.
Source: Medical Xpress; August 20, 2015.