藥物警訊

Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke

[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]

AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient

ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone.

Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.

BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.

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

美國FDA再更新有關2014年1月31日發布之testosterone藥物安全警訊。依據文獻證據及專家意見，FDA總結testosterone可能與增加心血管風險有關，並要求廠商應修改所有已上市之testosterone仿單，重申此藥品核准使用之適應症。美國FDA同時也要求廠商應於仿單中新增此類藥品可能增加心臟病發和中風風險之相關警語，另提醒testosterone目前僅核准用於男性缺乏testosterone之治療。治療老化testosterone濃度低下或與testosterone缺乏相關之男性症狀的療效及安全性尚未確立。

Testosterone為美國FDA核可用於治療男性因睪丸、腦下垂體或腦部障礙引起之性腺功能低下，導致體內testosterone濃度缺乏。美國FDA近來察覺此藥品被用於緩解男性因老化所造成的testosterone低下。然而，此用途之療效及安全性並未被確立。

Testosterone治療經實驗室數據報告證實其為特定因素導致體內testosterone濃度低下之病人。醫療人員應提醒病人使用此藥品可能發生之風險。若病人使用此藥後出現疑似心臟病發或中風等症狀，如胸痛、呼吸急促或困難、身體單側無力或言語不清，應立即就醫。
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