PMID- 35535587
OWN - NLM
STAT- MEDLINE
DCOM- 20220926
LR  - 20221207
IS  - 1556-9519 (Electronic)
IS  - 1556-3650 (Linking)
VI  - 60
IP  - 8
DP  - 2022 Aug
TI  - Ivermectin associated adverse events in the treatment and prevention of COVID-19 
      reported to the FACT pharmacovigilance project.
PG  - 942-946
LID - 10.1080/15563650.2022.2070187 [doi]
AB  - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
FAU - Farah, Rita
AU  - Farah R
AUID- ORCID: 0000-0002-7348-2624
AD  - Department of Emergency Medicine, Emory University, Atlanta, GA, USA.
AD  - Georgia Poison Center, Atlanta, GA, USA.
FAU - Kazzi, Ziad
AU  - Kazzi Z
AUID- ORCID: 0000-0002-9209-4301
AD  - Department of Emergency Medicine, Emory University, Atlanta, GA, USA.
AD  - Georgia Poison Center, Atlanta, GA, USA.
FAU - Brent, Jeffrey
AU  - Brent J
AUID- ORCID: 0000-0003-3763-4755
AD  - School of Medicine, University of Colorado, Aurora, CO, USA.
FAU - Burkhart, Keith
AU  - Burkhart K
AUID- ORCID: 0000-0001-8107-4818
AD  - United States Food and Drug Administration, Rockville, MD, USA.
FAU - Wax, Paul
AU  - Wax P
AD  - American College of Medical Toxicology, Phoenix, AZ, USA.
AD  - University of Texas Southwestern Medical Center, Dallas, TX, USA.
FAU - Aldy, Kim
AU  - Aldy K
AUID- ORCID: 0000-0002-3198-2321
AD  - American College of Medical Toxicology, Phoenix, AZ, USA.
AD  - University of Texas Southwestern Medical Center, Dallas, TX, USA.
CN  - Toxicology Investigators Consortium FACT Study Group
AD  - American College of Medical Toxicology, Phoenix, AZ, USA.
LA  - eng
PT  - Journal Article
DEP - 20220510
PL  - England
TA  - Clin Toxicol (Phila)
JT  - Clinical toxicology (Philadelphia, Pa.)
JID - 101241654
RN  - 70288-86-7 (Ivermectin)
SB  - IM
MH  - *COVID-19/prevention & control
MH  - Centers for Disease Control and Prevention, U.S.
MH  - Hospitalization
MH  - Humans
MH  - *Ivermectin/adverse effects
MH  - Pharmacovigilance
MH  - United States/epidemiology
MH  - *COVID-19 Drug Treatment
OTO - NOTNLM
OT  - COVID-19
OT  - adverse event
OT  - ivermectin
OT  - prevention
OT  - treatment
OT  - veterinary formulation
EDAT- 2022/05/11 06:00
MHDA- 2022/09/28 06:00
CRDT- 2022/05/10 04:52
PHST- 2022/05/11 06:00 [pubmed]
PHST- 2022/09/28 06:00 [medline]
PHST- 2022/05/10 04:52 [entrez]
AID - 10.1080/15563650.2022.2070187 [doi]
PST - ppublish
SO  - Clin Toxicol (Phila). 2022 Aug;60(8):942-946. doi: 10.1080/15563650.2022.2070187. 
      Epub 2022 May 10.