The FDA has mandated that the manufacturers of testosterone products carry out a large clinical trial or trials to prove not only the efficacy of supplementing the hormone, but also to determine the true risks — which may include heart attacks, stroke and even death. A revision of the labeling now requires clarification of the approved uses and a new safety warning. More importantly, the benefits are questionable. Over ten yeas ago, the prestigious Institute of Medicine reported that there was no definitive evidence that increasing the level of testosterone in older men had any benefit — or that it was safe. Some recently published studies have reaffirmed this.
I think the misinformation began with an article I remember reading many years ago in the authoritative New England Journal of Medicine that purported to show that the hormone built some strength and muscle mass. However, after a reanalysis of the data, the article was retracted. Some of the promoters of testosterone supplements mention only the first article. The FDA has stated that doctors should prescribe testosterone only when the medical condition is confirmed by laboratory tests and the risks are discussed. I believe that men should think very carefully before using it. Low T or not, as an “older” physician with no problems, I positively would not take it.