Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. For example, conditions when the testicles are not able to produce testosterone because of reasons such as a genetic problem or exposure to chemotherapy. Other examples include problems with the hypothalamus or pituitary gland that control the testicles’ production of testosterone.
Drug approval is not indicated for age-related hypogonadism, or the age-related decline of testosterone. A possible loophole that has allowed TRT usage in aging males was perhaps enabled by the inclusion in the indication of “idiopathic” hypogonadism and applying that term to age-related decline in testosterone.
Investigation is still underway and the FDA has not yet concluded that FDA-approved testosterone treatment does in fact increase the risk of stroke, heart attack, or death. Nevertheless, they are urging health care providers to consider whether the benefits of FDA approved testosterone treatment is likely to exceed the potential risks of treatment. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.