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[Posted 04/24/2020]
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 (2)
AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional
Hydroxychloroquine and chloroquine:
• are being studied in clinical trials for COVID-19, and FDA authorized their temporary use during the COVID-19 pandemic under limited circumstances through the EUA, and not through regular FDA approval.
• being used under the EUA when supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.
• can cause abnormal heart rhythms such as QT interval prolongation
• can cause dangerously rapid heart rate called ventricular tachycardia.
• pose risks that may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.
• should be used with caution in Patients who also have other health issues such as heart and kidney disease, who are likely to be at increased risk of these heart problems when receiving these medicines.
RECOMMENDATION:
Patients:
• Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed.
• The benefits of these medicines outweigh the risks at the recommended doses for these conditions.
• Do not stop taking your medicine without first talking to your health care professional and talk to them if you have any questions or concerns.
Be aware that there are no proven treatments for COVID-19 and no vaccine. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away by calling 911.
Hydroxychloroquine和chloroquine之建議：
• 此類藥品用於COVID-19正在進行臨床試驗研究，美國FDA透過EUA（而非通過常規美國FDA核准）授權可在COVID-19大流行期間，在有限的情況下供病人臨時使用此類藥品。
• 此類藥品由Strategic National Stockpile（在公衛緊急情況下重要醫療物資的國家儲備庫）提供時，是依據EUA授權下使用。
• 此類藥品可能導致異常心律，例如QT interval延長。
• 此類藥品會導致危險過快的心律，稱為心室心搏過速。
• 當這類藥物與已知會延長QT interval的其他藥物（包括抗生素azithromycin）合併使用時，可能會增加風險。即使目前尚未經美國FDA核准，部分COVID-19之病人仍會合併使用此組合治療。
• 在合併有其他共病症（例如心臟和腎臟疾病）的病人中，此類藥品應謹慎使用，因可能會增加此類病人出現心臟不良反應的風險。
病人：
• 使用hydroxychloroquine或chloroquine治療用途為美國FDA核准之適應症（瘧疾或自體免疫疾病）之病人，應繼續按處方服用藥物。
• 在上述情況下服用建議劑量，使用這類藥物的益處大於風險。
• 請勿在未與醫療專業人員討論前停止服藥，若有任何疑問或疑慮，請與醫療專業人員聯繫。
請注意，目前COVID-19尚未有經過證實之治療方法及疫苗。若正在接受hydroxychloroquine或 chloroquine治療 COVID-19時，出現心律不整，頭暈或暈厥，請立即撥打救護車專線，尋求醫療協助。
（待續）
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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