Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna.
Alma Mater Studiorum University of Bologna, Bologna, Italy.
Fundam Clin Pharmacol. 2022 Dec;36(6):1099-1105. doi: 10.1111/fcp.12797. Epub 2022 May 13.
At the beginning of the COVID-19 pandemic, worldwide attempts were made to identify potential drugs effective against the COVID-19. Hydroxychloroquine was among the first receiving attention. However, following its use in therapy, it has been shown that hydroxychloroquine was not only ineffective but probably, due to its known side effects, even responsible of increased mortality of patients. The objective of this study was to review the safety profile of hydroxychloroquine used off-label for the treatment of COVID-19. We analyze the reports of suspected adverse drug reactions (ADRs) collected in EudraVigilance, the European database of ADR reports. We collected 2266 reports for 2019 and 6525 for 2020. The most reported ADRs during 2020 were those relating to cardiac, hepatic, renal toxicity such as QT prolongation with 400 cases in 2020 (of which, 345 cases-9.97%-with COVID-19 as a therapeutic indication) versus 1 case only in 2019 (0.01%), long QT syndrome: 38 cases in 2020 (36 as COVID-19 treatment) versus 0 in 2019, hepatitis: 13 cases in 2019 (0.11%) and 132 in 2020, and 32 cases (24, 0.69%) of acute kidney injury in 2020 and only 3 cases in 2019. Moreover, some important vision-related ADRs also increased significantly during 2020, such as retinal toxicity with 92 cases in 2020 versus 7 in 2019. Even though with its intrinsic limitations, our results may be added to the most recent scientific evidence to confirm the unfavorable risk profile of hydroxychloroquine in its off-label use in the treatment of COVID-19 disease.
在 COVID-19 大流行初期，全球范围内都在努力寻找对 COVID-19 有效的潜在药物。羟氯喹就是首批受到关注的药物之一。然而，在将其用于治疗后，事实表明，羟氯喹不仅无效，而且由于其已知的副作用，甚至可能导致患者死亡率增加。本研究的目的是回顾羟氯喹在 COVID-19 治疗中的超说明书使用的安全性概况。我们分析了在 EudraVigilance 中收集的可疑药物不良反应（ADR）报告，EudraVigilance 是欧洲 ADR 报告数据库。我们收集了 2019 年的 2266 份报告和 2020 年的 6525 份报告。2020 年报告最多的不良反应是与心脏、肝脏、肾脏毒性相关的反应，如 QT 延长，2020 年有 400 例（其中 COVID-19 作为治疗指征的有 345 例，占 9.97%），而 2019 年仅 1 例（0.01%）；长 QT 综合征：2020 年有 38 例（36 例作为 COVID-19 治疗），2019 年无；肝炎：2019 年有 13 例（0.11%）和 2020 年有 132 例；2020 年有 32 例（24 例，占 0.69%）急性肾损伤，而 2019 年仅有 3 例。此外，2020 年一些重要的与视力相关的 ADR 也显著增加，如视网膜毒性，2020 年有 92 例，而 2019 年仅有 7 例。尽管存在内在局限性，但我们的结果可能有助于为最新的科学证据提供补充，以证实羟氯喹在 COVID-19 疾病治疗中的超说明书使用具有不利的风险特征。
