Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient
ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).
RECOMMENDATION:
Healthcare professionals should:
Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
Prescribe fluoroquinolones to these patients only when no other treatment options are available.
Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.
Patients should:
Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
Inform your health professional before starting an antibiotic prescription, if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
Not stop the antibiotic without first talking to your health care professional.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm
Fluoroquinolone類抗生素已被核可用於治療某些細菌感染超過30年，主要透過殺死或阻止可導致疾病的細菌生長而達到治療目的。某些感染如果不進行治療，可能會擴散並導致嚴重的健康問題。然而美國FDA審查發現，fluoroquinolone類抗生素可能增加發生主動脈(aorta)罕見但嚴重的破裂或撕裂之機率，此副作用稱為主動脈剝離(aortic dissections)或主動脈瘤破裂(ruptures of an aortic aneurysm)，其可能導致出血甚至死亡，發生於全身性作用的口服或注射fluoroquinolone類抗生素之使用。
醫療專業人員須知：避免開立fluoroquinolone類抗生素給有主動脈瘤或有主動脈瘤風險的病人，如患有周邊動脈血管粥狀硬化疾病、高血壓、或某些遺傳疾病（如：Marfan syndrome和Ehlers-Danlos syndrome）以及老年病人。
對此類病人，fluoroquinolone類抗生素僅限用於無其他治療可選擇時開立。提醒病人若出現任何主動脈瘤等相關症狀時，需立即就醫。若病人出現主動脈瘤或主動脈剝離等相關副作用時，需立即停止fluoroquinolone類抗生素治療。
病人須知：如果在胃部、胸部或背部突然出現嚴重且持續的疼痛，請立即前往急診或撥打119尋求醫療協助。
請注意，在主動脈瘤變大或破裂之前，其症狀通常不明顯，若使用fluoroquinolone類抗生素有任何異常副作用，請立即通知醫療專業人員。
如果有主動脈瘤、動脈阻塞或硬化、高血壓或某些遺傳疾病某些遺傳疾病(如：Marfan syndrome和Ehlers-Danlos syndrome)，請在開始使用抗生素治療前先告知醫療專業人員。
在未與醫療專業人員討論的情況下，請不要自行停止使用抗生素。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm?utm_campaign=FDA%20MedWatch%20-%20Fluoroquinolone%20Antibiotics&utm_medium=email&utm_source=Eloqua
更多訊息請參考FDA網址：
https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm
[Posted 12/20/2018]
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