Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems (3)
Consumers:
• Do not buy these medicines from online pharmacies without a prescription from your health care professional.
• Do not take any form of hydroxychloroquine or chloroquine that has not been prescribed for you by a health care provider. Serious poisoning and death have been reported after mistaken use of a chloroquine product not intended to be taken by humans.
• If you have these medicines in your home, keep them in childproof containers out of the reach of children to prevent accidental poisoning.
Health Professionals:
• FDA recommends initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials to treat or prevent COVID-19. Monitoring may include baseline ECG, electrolytes, renal function and hepatic tests.
• Be aware that hydroxychloroquine or chloroquine can:
－ cause QT prolongation
－ increase the risk of QT prolongation in patients with renal insufficiency or failure
－ increase insulin levels and insulin action causing increased risk of severe hypoglycemia
－ cause hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
－ interact with other medicines that cause QT prolongation even after discontinuing the medicines due to their long half-lives of approximately 30-60 days
If a health care professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and considering enrolling the patient. Consider using resources available to assess a patient's risk of QT prolongation and mortality.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medical-product-safety-information/hydroxychloroquine-or-chloroquine-covid-19-drug-safety-communication-fda-cautions-against-use?utm_campaign=FDA%20MedWatch%20Hydroxychloroquine%20or%20Chloroquine%20for%20COVID-19&utm_medium=email&utm_source=Eloqua
消費者：
• 未經醫療專業人員處方，請勿自行從線上藥局購買此類藥品。
• 非由醫療專業人員處方於自己之任何劑型的hydroxychloroquine或chloroquine請勿使用。有通報因為錯誤使用了非人類服用的chloroquine產品而導致嚴重中毒和死亡之案例。
• 若家中有此類藥品，請放在兒童安全包裝中，且置於兒童無法觸及的地方，以防止兒童意外中毒。
醫療專業人員：
• 美國FDA建議在EUA或臨床試驗中使用hydroxychloroquine或chloroquine治療或預防COVID-19時進行初步評估和監測。監測可能包括用藥前之心電圖(ECG)、電解質、腎功能和肝功能檢查。
• 請注意，hydroxychloroquine或chloroquine可能：
�� －導致QT延長。
�� －在腎功能不全或衰竭的病人，增加QT延長的風險。
�� －增加胰島素在體內的濃度和作用，導致嚴重低血糖的風險增加。
�� －導致G6PD缺乏症的病人溶血。
�� －此類藥品半衰期約為30-60天，故即使已經停藥，仍可能與其他導致QT延長的藥物發生交互作用。
如果醫療專業人員正在考慮使用hydroxychloroquine或chloroquine來治療或預防COVID-19，則美國FDA建議可確認www.clinicaltrials.gov是否有適當的臨床試驗可納入該名病人。考慮使用既有的資源來評估病人QT延長和死亡的風險。
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更多相關訊息與連結請參考FDA網址：https://reurl.cc/ZOMYLA
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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