藥物警訊

Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events

AUDIENCE: Cardiology, Urology, Family Practice

ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.

BACKGROUND: Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.

RECOMMENDATION: At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA發布藥品安全警訊，有關使用testosterone藥品之病人可能發生中風、心臟病發和死亡的風險，目前調查進行中。基於近期發表的兩篇研究認為接受testosterone治療之病人發生心血管事件的風險較高，FDA決議重新評估此藥之安全性並再公布最後結論。

背景

Testosterone為男性成長與性徵發展所需的荷爾蒙。FDA核准此類藥品適用於因testosterone缺乏或濃度低下產生相關症狀的男性病人。

建議

FDA目前尚未確立此藥品是否會增加中風、心臟病發甚至死亡等風險。醫療專業人員應遵循藥品仿單中之處方建議，並審慎評估病人使用testosterone治療的利弊。病人在未經醫療人員指示，請勿自行停藥，如有任何問題，請與醫療人員聯絡。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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