藥物警訊

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

AUDIENCE: Patient, Endocrinology, Internal Medicine

ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.

The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.

BACKGROUND: Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read the MedWatch safety alert, including a link to the FDA Statement, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526151.htm

含testosterone成分之處方藥為美國FDA核准用於治療如因先天性睪丸功能異常或因化療或感染導致睪丸功能受損之男性testosterone低下之荷爾蒙補充。

美國FDA在評估含testosterone或雄性類固醇成分藥品之相關發表文獻及案例報告後，公告將於所有含testosterone或雄性類固醇成分之藥品仿單中新增可能引起成癮性及依賴性之相關風險警語。

1990年之合成性類固醇管制法將合成性雄性類固醇 (含testosterone)列入管制成分之中。使用testosterone或雄性類固醇成分藥品可能導致成癮，且常見於運動員或健美人員。Testosterone成癮者，其使用劑量通常高於一般建議劑量，且常同時併用其他合成性雄性類固醇成分藥品，也較可能有嚴重安全性隱憂，如引起心臟病發、心衰竭、中風、憂鬱症、易怒、燥動、肝毒性及男性不孕症等。成癮者也曾被通報出現戒斷症狀，如抑鬱、疲倦、食慾不振、易怒、男性性功能障礙及失眠等。

美國FDA將於所有含testosterone成分之藥品仿單之濫用與成癮及警語與注意事項加註此資訊，提醒醫療人員此潛在的成癮性風險及嚴重不良後果，特別應注意此類藥品曾報導與心血管事件及心理健康有關。若病人疑似成癮，醫療人員應密切監測病人血中testosterone濃度，並觀察是否出現相關副作用。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526151.htm

[Posted 10/25/2016]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部