藥物警訊

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
Audience: Cardiology and endocrinology healthcare professionals
FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
● History of coronary artery disease (e.g., heart attack, angina)
● History of stroke or transient ischemic attack (TIA)
● History of heart arrhythmias
● History of congestive heart failure
● History of peripheral arterial disease
● Uncontrolled hypertension (e.g., > 145/90 mmHg)
Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA Follow-up Communication and the original November 2009 MedWatch alert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm
FDA發佈藥物安全警訊，通知醫護人員最新的研究資料顯示有心血管病史的病人使用含有sibutramine成份的藥品會增加心臟病發作及中風的風險。根據此重要的研究結果，FDA已要求且廠商也同意在sibutramine的藥品標示及仿單上加註使用禁忌，說明有下列心血管病史的病人禁止使用此類藥品，包括：
● 冠狀動脈疾病病史(心臟病、心絞痛等)
● 中風或短暫缺血性心臟病發作病史
● 心律不整病史
● 充血性心衰竭病史
● 週邊動脈疾病病史
● 未受控制的高血壓(收縮/舒張壓大於145/90 mmHg)
目前有使用含sibutramine成分藥品的病人應主動告知醫護人員以決定是否適合繼續服用。若對於治療有任何的問題，也可和醫護人員討論。 [Posted 01/21/2010]

相關訊息請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm

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