[OA] Off-Label Use and Misuse of Testosterone, Growth Hormone, Thyroid Hormone, and Adrenal Supplements: Risks and Costs of a Growing Problem
EXECUTIVE SUMMARY
1. Over the past few decades, there has been an unprecedented rise in off-label use and misuse of testosterone, growth hormone (GH), thyroid hormone, and adrenal supplements.
2. Testosterone therapy is indicated for the treatment of primary and secondary male hypogonadism. GH is approved by the U.S. Food and Drug Administration (FDA) for use in children and adults with GH deficiency. Thyroid hormone is indicated for the treatment of primary and secondary hypothyroidism. Glucocorticoids are indicated for the treatment of adrenal insufficiency and a wide array of inflammatory diseases.
3. “Adrenal fatigue” is an unrecognized entity that supposedly is due to the overuse of the adrenal glands, which may lead to a general sense of unwellness, fatigue, body aches, nervousness, sleep disturbances, digestive problems, weight gain, and a multitude of other nonspecific symptoms.
4. Many patients seek treatment for common nonspecific symptoms such as fatigue, low energy, poor sleep, weight gain, and lower libido. Unfortunately, some clinics and websites lead people to believe that their symptoms are attributable to a deficiency of a hormone and that treatment with this hormone will improve or eliminate their symptoms.
5. The off-label use and misuse of hormones and supplements in individuals without an established endocrine diagnosis carries known and unknown risks.
6. Dietary supplements do not undergo rigorous premarket safety and effectiveness testing and may contain undeclared pharmaceuticals.
7. Practitioners should undergo appropriate training to interpret laboratory test results in a more comprehensive way than simply checking whether a value falls within the reference range. There are many causes of abnormal laboratory results that are not due to hormonal deficiency or excess.
8. Patients should disclose to their providers off-label hormone use as it may affect their overall health, diagnostic testing, and treatment plan.
9. General medical practitioners and adult endocrinologists should be able to begin a discussion with their patients regarding the unfavorable balance between the risks and benefits associated with off-label use of testosterone, GH, thyroid hormone, and adrenal supplements.
Irwig MS, Fleseriu M, Jonklaas J, et al. Off-Label Use and Misuse of Testosterone, Growth Hormone, Thyroid Hormone, and Adrenal Supplements: Risks and Costs of A Growing Problem. Endocrine Practice 2020;26:340-53. https://doi.org/10.4158/PS-2019-0540
EXECUTIVE SUMMARY
1. Over the past few decades, there has been an unprecedented rise in off-label use and misuse of testosterone, growth hormone (GH), thyroid hormone, and adrenal supplements.
2. Testosterone therapy is indicated for the treatment of primary and secondary male hypogonadism. GH is approved by the U.S. Food and Drug Administration (FDA) for use in children and adults with GH deficiency. Thyroid hormone is indicated for the treatment of primary and secondary hypothyroidism. Glucocorticoids are indicated for the treatment of adrenal insufficiency and a wide array of inflammatory diseases.
3. “Adrenal fatigue” is an unrecognized entity that supposedly is due to the overuse of the adrenal glands, which may lead to a general sense of unwellness, fatigue, body aches, nervousness, sleep disturbances, digestive problems, weight gain, and a multitude of other nonspecific symptoms.
4. Many patients seek treatment for common nonspecific symptoms such as fatigue, low energy, poor sleep, weight gain, and lower libido. Unfortunately, some clinics and websites lead people to believe that their symptoms are attributable to a deficiency of a hormone and that treatment with this hormone will improve or eliminate their symptoms.
5. The off-label use and misuse of hormones and supplements in individuals without an established endocrine diagnosis carries known and unknown risks.
6. Dietary supplements do not undergo rigorous premarket safety and effectiveness testing and may contain undeclared pharmaceuticals.
7. Practitioners should undergo appropriate training to interpret laboratory test results in a more comprehensive way than simply checking whether a value falls within the reference range. There are many causes of abnormal laboratory results that are not due to hormonal deficiency or excess.
8. Patients should disclose to their providers off-label hormone use as it may affect their overall health, diagnostic testing, and treatment plan.
9. General medical practitioners and adult endocrinologists should be able to begin a discussion with their patients regarding the unfavorable balance between the risks and benefits associated with off-label use of testosterone, GH, thyroid hormone, and adrenal supplements.
Irwig MS, Fleseriu M, Jonklaas J, et al. Off-Label Use and Misuse of Testosterone, Growth Hormone, Thyroid Hormone, and Adrenal Supplements: Risks and Costs of A Growing Problem. Endocrine Practice 2020;26:340-53. https://doi.org/10.4158/PS-2019-0540
