藥物警訊（藥師週刊 第1717期）

FDA notified healthcare professionals that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns.

Death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.

BACKGROUND: Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.

The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information reviewed by the FDA, specifically postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary in Drug Safety Communication) as well as data from the medical literature. These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).

A Data Summary is provided in the Drug Safety Communication.

RECOMMENDATION: Based on FDA review, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.

Healthcare professional and patients should follow the recommendations in the "Additional Information for Healthcare Professionals/Patients" sections of the Drug Safety Communication.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communciation, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm

FDA提醒醫護人員注射劑terbutaline不應用於孕婦，作為預防或治療孕婦早產，可能會導致嚴重母體心臟方面的副作用及死亡，此外，口服terbutaline亦不應用來預防或治療早產，因為缺乏療效資料且安全性的考量與針劑相同。

曾有孕婦經口服或注射terbutaline延長治療而造成死亡或嚴重不良反應事件，包括心跳加快、間歇性血糖增高、低血鉀、心律不整、肺水腫及心肌梗塞的報告。

Terbutaline核准用於預防或治療氣喘、支氣管炎及肺氣腫伴隨的支氣管痙攣（氣道狹窄），有時候會用於非仿單標示之緊急產科的用途，包括治療早產及子宮過度刺激，亦有非仿單標示之更長時間使用以預防復發性早產。

基於FDA最新的terbutaline安全性報告，特別是上市後關於產科方面使用的安全性報告及文獻資料，決定於仿單加註加框警語及使用禁忌，此仿單變更與美國婦產科學會的陳述相符。

基於FDA回顧的資料後結論，孕婦注射terbutaline的延長治療（超過48-72小時）或口服terbutaline用於急性或延長治療，其嚴重不良反應事件的風險大於任何潛在的益處，FDA要求於仿單加註加框警語及使用禁忌以警告醫療人員此風險。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm

[Posted 02/17/2011]

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