Off-Label Use and Misuse of Testosterone,Growth Hormone,Thyroid Hormone,and Adrenal Supplements: Risks and Costs of a Growing Problem |
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| Affiliation: | 1. From George Washington University, Washington, DC;2. Oregon Health and Science University, Portland, Oregon;3. Georgetown University, Washington, DC;4. Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts;5. Barrow Neurological Institute, Phoenix, Arizona;6. University of Arizona College of Medicine-Phoenix, Phoenix, Arizona;7. Kansas University School of Medicine-Wichita, Wichita, Kansas;8. University of Mississippi, Jackson, Mississippi;9. Washington University in St. Louis, St. Louis, Missouri;10. University of Texas Southwestern Medical Center and VA Medical Center, Dallas, Texas;11. University College London Hospitals, London, United Kingdom;12. Federal University of Parana, Curitiba, Brazil;13. Mayo Clinic College of Medicine and Science, Rochester, Minnesota.;1. From the Division of Endocrinology, Boston Children''s Hospital, Boston, Massachusetts;2. Institutional Centers for Clinical and Translational Research, Boston Children''s Hospital, Boston, Massachusetts;3. Harvard Medical School, Boston, Massachusetts;4. Division of Pediatric Endocrinology, Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana;5. Division of Endocrinology, Seattle Children''s Hospital, Seattle, Washington;6. Division of Endocrinology and Center for Biobehavioral Health, Nationwide Children''s Hospital, Columbus, Ohio;7. Division of Pediatric Endocrinology, Cook Children''s Medical Center, Fort Worth, Texas.;1. From the Clinical Professor of Medicine Director, Metabolic Support Division of Endocrinology, Diabetes, and Bone Disease Icahn School of Medicine at Mount Sinai, New York, NY;2. Co-Director Memorial Center for Integrative Endocrine Surgery Hollywood, FL;3. Professor of Medicine University of Puerto Rico School of Medicine, Director Endocrinology Section University Hospital San Juan Puerto Rico, President AACE Puerto Rico Chapter, San Juan, Puerto Rico;4. Medical Director, Instituto Salvadoreño del Corazón, Unidad Diagnóstica de Osteoporosis, San Salvador, El Salvador;5. Internal Medicine and Endocrinology, Education Program Director in Diabetes and Risk Factors, Thyroid and Diabetes Clinical Management Director, Hospital Bendaña, Honduras, CA;6. Scientific Director, Colombian Diabetes Association, Professor Endocrinology and Clinical Epidemiology, Javeriana University and San Ignacio University Hospital, Bogotá;, Colombia;7. Professor of Medicine, Loyola University Medical Center, Director, Loyola University Osteoporosis and Metabolic Bone Disease Center, Maywood, IL;8. Clinical Professor of Internal, Medicine Division of Internal Medicine, Hospital General “Dr. Manuel Gea González” México City, Mexico;9. Division of Endocrinology, Hospital Cima Director of San Agustin Research Center San José, Costa Rica;10. Catholic University of Rio de Janeiro, State Institute of Diabetes and Endocrinology;11. Clinical Professor of Medicine, Touchstone Diabetes Center, The University of Texas Southwestern Medical Center Dallas, TX;12. Endocrine Division, Harvard Vanguard Medical Associates, Division of Endocrinology, Beth Israel Deaconess Medical Center Boston, MA;13. Department of Nutrition Sciences and the UAB Diabetes Research Center, University of Alabama at Birmingham, and The Birmingham Veterans Affairs Medical Center Birmingham, AL;14. Professor, Faculty of Medicine, UANL: Nutrition, Endocrinology, Internal Medicine, Education Coordinator Endocrinology Service, Hospital Universitario, UANL, Head of the Diabetes Clinic of the Hospital Universitario “Dr. José E. González” UANL, Regional Hospital endocrinologist ISSSTE Monterrey, Policy Coordinating Group for Treatment of Diabetes in the Official Mexican Standar State Program Coordinator for Healthy Eating and Physical Activity Monterrey, Nuevo Leon, Mexico;15. Internal Medicine and Endocrinology Hospital Alemá;n Nicaraguense Hospital Metropolitano Vivian Pellas, Professor Endocrinology and Internal Medicine Universidad Nacional Autónoma de Nicaragua Managua, Nicaragua;16. Medical Director, Obesity Clinical Program, Director of Inpatient Diabetes Program, Joslin Diabetes Center, Harvard Medical School Boston, MA;17. Medical Director & Principal Investigator, Metabolic Institute of America Tarzana, CA;18. President Costa Rican Association of Endocrinologists (ANPEDEM), Professor Endocrinology and Internal Medicine, University of Costa Rica Coordinator Endocrinology Department, Hospital San Vicente de Paul, Costa Rica;19. Medical Director, Thyroid & Endocrine Center of Florida Assistant Clinical Professor, Florida State University College of Medicine, Sarasota, FL;20. Full Professor of Biochemistry and Nutrition, Dean School of Medicine, University of Panama, Panama;21. Professor of Medicine, Dean Post Graduate Studies, Universidad de Ciencias Médicas Head of the Division of Endocrinology Hospital CIMA, Escasu, San Jose, Costa Rica;22. Consultant in Endocrinology Medical Director, Endocrine, Diabetes & Osteoporosis Clinic (EDOC), Sterling, VA.;1. From the Department of Internal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts;2. the Division of Newborn Medicine, Boston Children''s Hospital, Harvard Medical School, Boston, Massachusetts;3. Ansh Labs, Webster, Texas;4. the Department of Pediatric Newborn Medicine, Brigham & Women''s Hospital, Harvard Medical School, Boston, Massachusetts;5. Section of Endocrinology, Boston VA Healthcare System, Harvard Medical School, Boston, Massachusetts. |
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| Abstract: | Over the past few decades, there has been an unprecedented rise in off-label use and misuse of testosterone, growth hormone, thyroid hormone, and adrenal supplements. Testosterone therapy is often promoted to men for the treatment of low energy, lower libido, erectile dysfunction, and other symptoms. Growth hormone is used in attempts to improve athletic performance in athletes and to attenuate aging in older adults. Thyroid hormone and/or thyroid supplements or boosters are taken to treat fatigue, obesity, depression, cognitive impairment, impaired physical performance, and infertility. Adrenal supplements are used to treat common nonspecific symptoms due to “adrenal fatigue,” an entity that has not been recognized as a legitimate medical diagnosis. Several factors have contributed to the surge in off-label use and misuse of these hormones and supplements: direct-to-consumer advertising, websites claiming to provide legitimate medical information, and for-profit facilities promoting therapies for men's health and anti-aging. The off-label use and misuse of hormones and supplements in individuals without an established endocrine diagnosis carries known and unknown risks. For example, the risks of growth hormone abuse in athletes and older adults are unknown due to a paucity of studies and because those who abuse this hormone often take supraphysiologic doses in sporadic intervals. In addition to the health risks, off-label use of these hormones and supplements generates billions of dollars of unnecessary costs to patients and to the overall health-care system. It is important that patients honestly disclose to their providers off-label hormone use, as it may affect their health and treatment plan. 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, growth hormone, thyroid hormone, and adrenal supplements.Abbreviations: DHEA = dehydroepiandrosterone; FDA = U.S. Food and Drug Administration; GH = growth hormone; IGF-1 = insulin-like growth factor 1; LT3 = L-triiodothyronine; LT4 = levothyroxine; T3 = total triiodothyronine; T4 = thyroxine; TSH = thyroid-stimulating hormone |
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