| Abacavir - Ongoing Safety Review：Possible Increased Risk of Heart Attack
including Ziagen, Trizivir, and Epzicom
AUDIENCE: Infectious Disease
FDA updated the public about？an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.
FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.
BACKGROUND：Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.
RECOMMENDATION：Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online：www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245190.htm
FDA公告更正有關abacavir可能增加心臟病發風險的安全性報告，與之前abacavir增加心臟病發風險的研究結果不同，在許多觀測研究及一項隨機臨床對照研究中發現abacavir可能增加心臟病發（心肌梗塞）的風險，但在其他的隨機臨床對照研究及藥廠的安全資料庫中卻無此結果。FDA對26個評估abacavir的隨機臨床對照研究進行統合分析，結果並未顯示abacavir會增加心肌梗塞的風險，未來若有任何安全性的資訊FDA將會持續公告大眾。
Abacavir是一種抗病毒藥物，與其他抗反轉錄病毒藥物併用治療HIV-1感染。FDA建議醫療專業人員仍應持續處方abacavir，病人在未經醫師同意前不應停止服用abacavir。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245190.htm
[Posted 03/01/2011]
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 |
資料來源：藥師週刊（第1721期）