There is no proof that testosterone replacement therapy is safe and effective for aging men, Food and Drug Administration (FDA) authorities said in a paper published in the Aug. 20 edition of the New England Journal of Medicine.
Testosterone supplements have been heavily marketed to men as a treatment for so-called Low-T, or low testosterone levels. The ads ask men if they suffer from symptoms of this condition, which include low libido, weight loss and muscle loss. The marketing has been so successful that prescriptions for the hormone have jumped into the millions. Between 2009 and 2013, the number of U.S. men taking testosterone treatments jumped from 1.3 million to 2.3 million.
Testosterone treatments, however, are designed specifically for men with hypogonadism, a condition in which men do not produce enough testosterone due to damage or disease to the testes. Men also experience a natural drop in testosterone as they age, which is considered a natural part of the aging process and not something to treat.
Recent studies have shown that men on testosterone therapy are at an increased risk of heart attacks, strokes and death. Last year, the FDA ordered that all prescription testosterone treatments carry a warning for cardiovascular side effects.
Testosterone supplements provide benefit for men with hypogonadism, the FDA said, but the hormones have little – if any – benefit for men who experience a drop in testosterone due to aging. And in that case, the agency added, the risks of treatment likely outweigh the benefits.