Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain serious 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.
Most fluoroquinolone antibiotic drug labels include a warning that blood sugar disturbances, including high blood sugar and low blood sugar and depending on the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug.
RECOMMENDATION: The new label changes will add that low blood sugar levels, also called hypoglycemia, can lead to coma and the new label will also make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are:disturbances in attention、disorientation、agitation、nervousness、memory impairment、serious disturbances in mental abilities called delirium.
FDA continues to monitor and evaluate the safety and effectiveness of medicines after we approve them and they go on the market. In the case of fluoroquinolones, we reviewed reports of cases submitted to FDA and the published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.
Patients should tell your health care professionals if you are taking a diabetes medicine when your health care professional is considering prescribing an antibiotic, and also if you have low blood sugar or symptoms of it while taking a fluoroquinolone. For patients with diabetes, your health care professional may ask you to check your blood sugar more often while taking a fluoroquinolone. Early signs and symptoms of low blood sugar include:Confusion、pounding heart or very fast pulse、dizziness、pale skin、feeling shaky、sweating、unusual hunger、trembling、headaches、weakness、irritability、unusual anxiety
Health care professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin.
Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia.
Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose.
Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non-fluoroquinolone antibiotic if possible.
Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non-fluoroquinolone antibiotic to complete the patient's treatment course.
Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm?utm_campaign=FDA%20MedWatch%20-%20%20Fluoroquinolone%20Antibiotics%3A%20FDA%20Requires%20Labeling&utm_medium=email&utm_source=Eloqua
美國FDA持續監測和評估已上市藥品之安全性和有效性，以fluoroquinolone類抗生素為例，fluoroquinolone類抗生素可殺菌或抑制細菌生長，故核可用於治療某些嚴重細菌感染已逾30年。多數fluoroquinolone類抗生素仿單中已包含可能會造成血糖不穩（包含高血糖或低血糖）之警訊；而根據不同fluoroquinolone類抗生素，亦已於中樞神經系統之警訊中加註精神方面相關副作用。美國FDA審查通報之案例及回顧相對健康之病人接受全身性fluoroquinolone類抗生素治療時之精神健康、行為和血糖值之相關醫學文獻，並針對新的fluoroquinolone類抗生素之仿單加強相關警訊：增加低血糖產生而導致昏迷；更加凸顯並統一其精神方面相關副作用（包含注意力不集中、迷失方向、躁動、緊張、記憶障礙及譫妄等）之警訊。
病人使用fluoroquinolone類抗生素時，若合併使用糖尿病藥品，需告知醫療專業人員；糖尿病之病人如使用fluoroquinolone類抗生素，亦需更加密集測量血糖值。早期低血糖的症狀和徵兆可能包含：混亂、心跳加速、頭暈、皮膚蒼白、覺得搖晃、冒汗、異常飢餓、顫抖、頭痛、虛弱、易怒煩躁、異常焦慮等。
醫療專業人員應提醒病人低血糖有時可能造成昏迷，特別是在老年人或是使用糖尿病藥物之病人身上。因此因告知病人低血糖之相關症狀，且建議上述高低血糖風險之病人需密集監控血糖值。除此之外，也因提醒病人精神相關副作用亦可能會出現在服用第一劑之fluoroquinolone類抗生素。若病人出現任何中樞神經系統方面的副作用，包含精神相關副作用、血糖值不穩等，請立即停止fluoroquinolone類抗生素，如有替代藥品應更換成其他非fluoroquinolone類抗生素。若病人出現肌腱、肌肉、關節或神經相關嚴重副作用，亦需立即停止fluoroquinolone類抗生素，並更換其他非fluoroquinolone類抗生素直至完成療程。
急性細菌性鼻竇炎、急性細菌性惡化之慢性支氣管炎和無併發症的尿路感染，因使用fluoroquinolone類抗生素之風險大於益處，宜優先考慮其他治療方法。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm?utm_campaign=FDA%20MedWatch%20-%20%20Fluoroquinolone%20Antibiotics%3A%20FDA%20Requires%20Labeling&utm_medium=email&utm_source=Eloqua
[Posted 07/10/2018]
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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