Department of Emergency Medicine, Emory University, Atlanta, GA, USA.
Georgia Poison Center, Atlanta, GA, USA.
Clin Toxicol (Phila). 2022 Aug;60(8):942-946. doi: 10.1080/15563650.2022.2070187. Epub 2022 May 10.
In August 2021, the Centers for Disease Control and Prevention (CDC) released a health alert following the rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin for the prevention or treatment of COVID-19 infections. The United States Food and Drug Administration (FDA) and the CDC have explicitly discouraged the use of ivermectin in the prevention or treatment of COVID-19 outside of clinical trials. The study aims to describe the adverse events (AEs) related to ivermectin use for the prevention or treatment of COVID-19.
This is a prospective case series of adverse events related to therapeutics used in the prevention or treatment of COVID-19 submitted to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project sub-registry between October 2020 and December 2021. This is an ongoing toxico-surveillance system at 15 major academic medical centers in 12 states. Data collected included sociodemographics, exposure related information including dose, frequency, route, duration, and reason for taking ivermectin as well as a clinical description of the adverse event and the outcome.
A total of 40 patients who developed AEs following ivermectin use were reported to FACT over 15 months. Self-medication with veterinary formulations were reported in 18/40 patients Thirty-three patients presented to emergency departments and nineteen patients were admitted to the hospital. Patients reported using ivermectin for prevention (24/40), treatment of symptoms (19/40), and for treatment of documented COVID-19 (8/40). Neurological toxicity was the most frequent finding. Fifteen patients had minor symptoms while 25 developed severe toxicity.
Ivermectin use for the attempted treatment of COVID-19 has potential adverse health effects primarily related to neurological function. This is especially true when patients are self-treating with this medication and when they are using formulations intended for non-human use.
2021 年 8 月，美国疾病控制与预防中心（CDC）在伊维菌素处方数量迅速增加以及因使用含有伊维菌素的产品预防或治疗 COVID-19 感染而导致严重疾病的报告后发布了健康警报。美国食品和药物管理局（FDA）和 CDC 明确劝阻在临床试验之外将伊维菌素用于预防或治疗 COVID-19。本研究旨在描述与预防或治疗 COVID-19 相关的伊维菌素使用的不良事件（AE）。
这是一项前瞻性病例系列研究，涉及在 2020 年 10 月至 2021 年 12 月期间向 FDA ACMT COVID-19 ToxIC（FACT）药物警戒项目子登记处提交的与预防或治疗 COVID-19 相关的治疗不良事件。这是在 12 个州的 15 个主要学术医疗中心进行的正在进行的毒理学监测系统。收集的数据包括社会人口统计学资料、与暴露相关的信息，包括剂量、频率、途径、持续时间和服用伊维菌素的原因，以及不良事件的临床描述和结果。
在 15 个月内，FACT 共报告了 40 例使用伊维菌素后发生 AE 的患者。40 例患者中有 18 例报告自行使用兽医制剂。33 例患者到急诊室就诊，19 例患者住院。患者报告使用伊维菌素预防（24/40）、治疗症状（19/40）和治疗有记录的 COVID-19（8/40）。神经毒性是最常见的发现。15 名患者有轻微症状，25 名患者出现严重毒性。
试图用伊维菌素治疗 COVID-19 可能会产生不良健康影响，主要与神经功能有关。当患者自行用这种药物治疗，并且使用非人类用药的制剂时，情况尤其如此。
