PMID- 37377231
OWN - NLM
STAT- MEDLINE
DCOM- 20230629
LR  - 20230629
IS  - 1726-4642 (Electronic)
IS  - 1726-4634 (Linking)
VI  - 40
IP  - 1
DP  - 2023 Jan-Mar
TI  - Characterization of adverse events to hydroxychloroquine, ivermectin, 
      azithromycin and tocilizumab in patients hospitalized due to COVID-19 in a 
      Peruvian Social Health Insurance hospital.
PG  - 16-24
LID - 10.17843/rpmesp.2023.401.11563 [doi]
AB  - OBJECTIVE. To characterize the adverse events (AEs) related to the off-label use 
      of hydroxychloroquine (HQ), azithromycin (AZI), tocilizumab (TOB) and ivermectin 
      (IVM) for the treatment of COVID-19 in hospitalized patients. MATERIALS AND 
      METHODS. We conducted a secondary cross-sectional analysis of the Peruvian Social 
      Health Insurance (EsSalud) pharmacovigilance system database of AE notifications 
      to HQ, AZI, TOB and IVM in the Edgardo Rebagliati Martins National Hospital from 
      April to October 2020. Information was collected from digital medical records. We 
      estimated AE reporting rates and evaluated their characteristics by drug type, 
      time of occurrence, type by the affected organ-system, severity and causality. 
      RESULTS. We identified 154 notifications describing a total of 183 AE possibly 
      related to HQ, AZI, TOB and IVM; the reporting rate was 8%. The median time of AE 
      occurrence was 3 days (IQR: 2-5). Most were cardiovascular events; prolongation 
      of the QT interval was the most frequent. Hepatobiliary AEs were mainly 
      associated with TOB. Most cases were moderate, however, 10.4% were severe. 
      CONCLUSIONS. We found AEs potentially associated with the use of HQ, AZI, TOB and 
      IVM against COVID-19; cardiovascular events were the most frequent. Although AZI, 
      HQ and IVM have known safety profiles, their use against COVID-19 could increase 
      the occurrence of AE due to the risk factors inherent to this infection. 
      Surveillance systems must be improved, especially those for TOB.
FAU - Rodriguez-Tanta, L Yesenia
AU  - Rodriguez-Tanta LY
AUID- ORCID: 0000-0002-6510-7795
AD  - Instituto de Evaluacion de Tecnologias en Salud e Investigacion - IETSI, EsSalud, 
      Lima, Peru.
FAU - Cachay Rojas, Enrique
AU  - Cachay Rojas E
AUID- ORCID: 0000-0003-2600-9006
AD  - Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
FAU - Fiestas Saldarriaga, Fabian
AU  - Fiestas Saldarriaga F
AUID- ORCID: 0000-0002-9158-443X
AD  - Instituto Nacional de Salud, Lima, Peru.
FAU - Alva Lozada, Guisela
AU  - Alva Lozada G
AUID- ORCID: 0000-0002-8077-3059
AD  - Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Peru.
FAU - Fernandez-Rojas, Paola
AU  - Fernandez-Rojas P
AUID- ORCID: 0000-0002-0500-2377
AD  - Instituto de Evaluacion de Tecnologias en Salud e Investigacion - IETSI, EsSalud, 
      Lima, Peru.
FAU - Delgado-Escalante, Raquel
AU  - Delgado-Escalante R
AUID- ORCID: 0000-0002-0180-2254
AD  - Instituto de Evaluacion de Tecnologias en Salud e Investigacion - IETSI, EsSalud, 
      Lima, Peru.
LA  - spa
LA  - eng
PT  - Journal Article
TT  - Caracterizacion de los eventos adversos a hidroxicloroquina, ivermectina, 
      azitromicina y tocilizumab en pacientes hospitalizados por la COVID-19 en un 
      hospital del Seguro Social de Salud del Peru.
DEP - 20230623
PL  - Peru
TA  - Rev Peru Med Exp Salud Publica
JT  - Revista peruana de medicina experimental y salud publica
JID - 101227566
RN  - 4QWG6N8QKH (Hydroxychloroquine)
RN  - 83905-01-5 (Azithromycin)
RN  - I031V2H011 (tocilizumab)
RN  - 70288-86-7 (Ivermectin)
SB  - IM
MH  - Humans
MH  - Hydroxychloroquine
MH  - *COVID-19
MH  - Azithromycin/adverse effects
MH  - Ivermectin
MH  - Cross-Sectional Studies
MH  - Peru/epidemiology
MH  - COVID-19 Drug Treatment
MH  - Insurance, Health
MH  - Hospitals
MH  - *Cardiovascular Diseases
EDAT- 2023/06/28 13:08
MHDA- 2023/06/29 06:42
CRDT- 2023/06/28 08:15
PHST- 2022/06/19 00:00 [received]
PHST- 2023/01/25 00:00 [accepted]
PHST- 2023/06/29 06:42 [medline]
PHST- 2023/06/28 13:08 [pubmed]
PHST- 2023/06/28 08:15 [entrez]
AID - 10.17843/rpmesp.2023.401.11563 [doi]
PST - ppublish
SO  - Rev Peru Med Exp Salud Publica. 2023 Jan-Mar;40(1):16-24. doi: 
      10.17843/rpmesp.2023.401.11563. Epub 2023 Jun 23.