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藥物警訊

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   資料來源:藥師週刊(第1913期)
   記者: 
   日期:04月20日
 
   

 

 

 

Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction

AUDIENCE: Family Practice, Patient, Pulmonology

ISSUE: FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. Refer to the Drug Safety Communication for a detailed data summary.

BACKGROUND: Chantix is a prescription medicine that is FDA-approved to help adults quit smoking.

RECOMMENDATION: Healthcare professionals should weigh the potential risk of seizures against the potential benefits before prescribing Chantix in patients with a history of seizures or other factors that can lower the seizure threshold. Advise patients to immediately stop taking Chantix if they develop agitation, hostility, aggressive behavior, depressed mood, or changes in behavior or thinking that are not typical for them, or if they develop suicidal ideation or behavior.

Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.

Read the MedWatch Safety Alert, including links to the Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA發布安全警訊,戒菸藥品Chantix (varenicline)可能改變病人對於酒精的反應。酒精與Chantix之交互作用可能改變病人對酒精之耐受性,及伴隨攻擊行為和/或失憶。除此之外,也曾有極少數病人服用Chantix後出現癲癇症狀之案例。美國FDA已核准藥品仿單新增與此風險相關之警語。

Chantix為FDA核可用於幫助戒菸之處方藥品。對於曾有癲癇病史之病人,醫療人員應先衡量其發生癲癇的風險或其他可能降低癲癇閾值之因素與使用此藥之利益。若出現攻擊行為、憂鬱情緒、行為改變或產生自殺意念或行為等,應立即停用Chantix。

服用此藥之病人應減少酒精的攝取量直到了解Chantix影響其對酒精耐受的能力為何。病人在服用Chantix期間若發生癲癇症狀應立即停藥並就醫。

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