Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease
AUDIENCE: Health Professional, Internal Medicine, Cardiology, Patient
ISSUE: FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDAs recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.
The large clinical trial, called the CLARICOR trial, observed an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients had been followed for one year or longer. There is no clear explanation for how clarithromycin would lead to more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not. All the studies had limitations in how they were designed. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not. Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results. Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease.
As a result, FDA added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients. FDA also added the study results to the clarithromycin drug labels. As part of FDA's usual ongoing safety monitoring of drugs, we are continuing to monitor safety reports in patients taking clarithromycin.
BACKGROUND: Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with human immunodeficiency virus (HIV). Clarithromycin is not approved to treat heart disease.
RECOMMENDATION: Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.
Patients should tell your healthcare professionals if you have heart disease, especially when you are being prescribed an antibiotic to treat an infection. Talk to them about the benefits and risks of clarithromycin and any alternative treatments. Do not stop taking your heart disease medicine or antibiotic without first talking to your healthcare professionals. Doing so could be harmful without your health care professionals' direct supervision. Seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of your body, or slurred speech.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm
Clarithromycin用於治療皮膚、鼻竇、肺和身體等其他部位之感染，包括治療人類免疫缺乏病毒（human immunodeficiency virus, HIV）感染者後續可能感染之鳥分枝桿菌複合體（Mycobacterium avium complex , MAC）。Clarithromycin目前未被核准使用於治療心臟病。
美國FDA根據一追蹤冠心病病人10年之大型臨床試驗研究結果，發布藥物安全警訊，建議開立抗生素clarithromycin（Biaxin）於心臟病病人前需審慎評估，因為用藥後幾年可能會出現心臟病或死亡之風險。
此大型臨床試驗CLARICOR其研究結果顯示，接受clarithromycin兩週療程的冠心病病人，其死亡率增加，尤其是追蹤病人一年以上其結果更明顯。目前對於clarithromycin相較於安慰劑，為何導致更多的死亡無明確的解釋。由於所有的研究在研究設計方面都有所限制，一些觀察性研究針對此安全性議題，有不一致的結果。無論有無冠狀動脈疾病的病人使用clarithromycin，於迄今為止發表的六個觀察性研究中，其中有兩個研究顯示有長期風險的可能，另外四個研究則沒有。整體而言，前瞻性、安慰劑對照之CLARICOR試驗的結果，相較於觀察性研究結果，提供使用clarithromycin其長期風險增加的最有力證據。然而根據這些研究，美國FDA仍無法確定為什麼心臟病病人使用clarithromycin的死亡風險更高。
對於此安全性議題，美國FDA建議處方者在這類病人中應考慮使用其他抗生素，美國FDA亦將此藥物安全警訊新增至clarithromycin仿單中。美國FDA會持續監測服用clarithromycin病人的安全性報告。
醫療專業人員應在給予任何病人（特別是心臟病病人，即使短期服用）處方clarithromycin前，評估其對病人的益處和風險，並考慮使用其他抗生素。無論使用clarithromycin治療何種感染，皆需提醒心臟病病人注意心臟相關問題的症狀和癥兆。
病人若有心臟病，特別是需要使用抗生素治療時，應告知醫療專業人員，並與醫療專業人員討論使用clarithromycin或其他治療方法的益處和風險。請勿在未諮詢醫療專業人員前，自行停用心臟疾病藥品或抗生素，此舉可能會造成其他問題。若遇到心臟病發作或中風的症狀，如胸痛、呼吸困難、身體一部分疼痛或虛弱、言語不清，請立即就醫。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm
[Posted 2/22/2018]
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
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