Heart attack and stroke risk prompted the FDA to require the makers of prescription testosterone drugs to include warnings on their labels. These drugs were originally intended for patients with medical causes -- such as conditions involving the testicles or pituitary glad -- for low testosterone. However, the plethora of advertising for "low-t" drugs are aimed at aging men who may be experiencing a natural decrease in testosterone, which begins to decline around age 40. Such marketing led to a dramatic increase in the number of men who have been prescribed testosterone-replacement.
According to USA Today, of the estimated 1.5 million men using testosterone as of 2013, only half were diagnosed with low testosterone due to medical conditions, and just a quarter ever had their testosterone levels tested. The drugs are often prescribed based on the symptoms of low libido, weight gain, fatigue, and mood swings.
Recent studies linking testosterone use to an increased risk of heart attack and stroke raised concern. A 2014 NIH study showed men over 65 who used testosterone drugs had twice the risk of heart attack than those not using them. Younger men with a history of heart disease had nearly triple the risk.
In light of such evidence, the Canadian Health Agency issued a warning concerning the use of the drugs. The Wall Street Journal reports the Public Health Research Group requested the FDA do the same in February, 2014. Dr. Sidney Wolfe, the organization's founder and senior adviser, claims the lack of action by the FDA was due to pressure from doctors and the drug companies marketing testosterone drugs.
"The FDA is more sensitive to pressure from doctors … and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators."Boston-based urologist Dr. Abraham Morgentaler disagrees with the warnings, saying the studies are flawed, and warning labels are "bad news for men," and "will make it even more difficult for men suffering from true testosterone deficiency." The benefits of testosterone supplementation in cases of medical necessity may include increased sexual function, bone density, lean muscle mass, and decreased cholesterol.
The maker of AndroGel -- Abbvie Inc. -- and the maker of Axiron -- Eli Lilly & Co. -- both express concern for patient safety, and say they plan to cooperate with the FDA. Consumers and their doctors are cautioned that the benefits of testosterone therapy in men with age-related low testosterone have yet to be proven greater than the risks of heart attack and stroke. WebMD notes that some ways to possibly increase testosterone naturally are exercise, maintaining a healthy weight, and getting plenty of quality sleep.
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