Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data

BACKGROUND: From March to April 2020, Spain was the center of the SARS-CoV-2 pandemic, particularly Madrid with approximately 30% of the cases in Spain. The aim of this study is to report the suspected serious adverse drug reactions (SADRs) in COVID-19 patients vs. non-COVID-19 patients detected by...

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Autores: Ramírez García, Elena, Urroz, Mikel, Rodríguez, Amelia, González-Muñoz, Miguel, Martín-Vega, Alberto, Villán, Yuri, Seco, Enrique, Monserrat, Jaime, Frías Iniesta, Jesús A., Carcas Sansuán, Antonio Javier, Borobia Pérez, Alberto M.
Tipo de recurso: artículo
Fecha de publicación:2020
País:España
Institución:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/695720
Acceso en línea:http://hdl.handle.net/10486/695720
https://dx.doi.org/10.3389/fphar.2020.602841
Access Level:acceso abierto
Palabra clave:adverse (side) effects
adverse drug reaction
corona virus disease-19 (COVID-19)
pharmacovigilance process
serious adverse drug reaction
Farmacia
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spelling Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary dataRamírez García, ElenaUrroz, MikelRodríguez, AmeliaGonzález-Muñoz, MiguelMartín-Vega, AlbertoVillán, YuriSeco, EnriqueMonserrat, JaimeFrías Iniesta, Jesús A.Carcas Sansuán, Antonio JavierBorobia Pérez, Alberto M.adverse (side) effectsadverse drug reactioncorona virus disease-19 (COVID-19)pharmacovigilance processserious adverse drug reactionFarmaciaBACKGROUND: From March to April 2020, Spain was the center of the SARS-CoV-2 pandemic, particularly Madrid with approximately 30% of the cases in Spain. The aim of this study is to report the suspected serious adverse drug reactions (SADRs) in COVID-19 patients vs. non-COVID-19 patients detected by the prospective pharmacovigilance program based on automatic laboratory signals (ALSs) in the hospital (PPLSH) during that period. We also compared the results with the suspected SADRs detected during the same period for 2019. METHODS: All ALSs that reflected potential SADRs including neutropenia, pancytopenia, thrombocytopenia, anemia, eosinophilia, leukocytes in cerebrospinal fluid, hepatitis, pancreatitis, acute kidney injury, rhabdomyolysis, and hyponatremia were prospectively monitored in hospitalized patients during the study periods. We analyzed the incidence and the distribution of causative drugs for the COVID-19 patients. RESULTS: The incidence rate of SADRs detected in the COVID-19 patients was 760.63 (95% CI 707.89–816.01) per 10,000 patients, 4.75-fold higher than the SADR rate for non-COVID-19 patients (160.15 per 10,000 patients, 95% CI 137.09–186.80), and 5.84-fold higher than the SADR rate detected for the same period in 2019 (130.19 per 10,000 patients, 95% CI 109.53–154.36). The most frequently related drugs were tocilizumab (59.84%), dexketoprofen (13.93%), azithromycin (8.43%), lopinavir-ritonavir (7.35%), dexamethasone (7.62%), and chloroquine/hydroxychloroquine (6.91%). CONCLUSIONS: The incidence rate of SADRs detected by the PPSLH in patients with COVID-19 was 4.75-fold higher than that of the non-COVID-19 patients. Caution is recommended when using medications for COVID-19 patients, especially drugs that are hepatotoxic, myotoxic, and those that induce thromboembolic events.Frontiers MediaDepartamento de FarmacologíaFacultad de Medicina20202020-12-03research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/695720https://dx.doi.org/10.3389/fphar.2020.602841reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/6957202026-06-23T12:46:27Z
dc.title.none.fl_str_mv Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
title Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
spellingShingle Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
Ramírez García, Elena
adverse (side) effects
adverse drug reaction
corona virus disease-19 (COVID-19)
pharmacovigilance process
serious adverse drug reaction
Farmacia
title_short Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
title_full Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
title_fullStr Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
title_full_unstemmed Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
title_sort Incidence of suspected serious adverse drug reactions in corona virus Ddsease-19 patients detected by a pharmacovigilance program by laboratory signals in a tertiary hospital in Spain: Cautionary data
dc.creator.none.fl_str_mv Ramírez García, Elena
Urroz, Mikel
Rodríguez, Amelia
González-Muñoz, Miguel
Martín-Vega, Alberto
Villán, Yuri
Seco, Enrique
Monserrat, Jaime
Frías Iniesta, Jesús A.
Carcas Sansuán, Antonio Javier
Borobia Pérez, Alberto M.
author Ramírez García, Elena
author_facet Ramírez García, Elena
Urroz, Mikel
Rodríguez, Amelia
González-Muñoz, Miguel
Martín-Vega, Alberto
Villán, Yuri
Seco, Enrique
Monserrat, Jaime
Frías Iniesta, Jesús A.
Carcas Sansuán, Antonio Javier
Borobia Pérez, Alberto M.
author_role author
author2 Urroz, Mikel
Rodríguez, Amelia
González-Muñoz, Miguel
Martín-Vega, Alberto
Villán, Yuri
Seco, Enrique
Monserrat, Jaime
Frías Iniesta, Jesús A.
Carcas Sansuán, Antonio Javier
Borobia Pérez, Alberto M.
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Farmacología
Facultad de Medicina
dc.subject.none.fl_str_mv adverse (side) effects
adverse drug reaction
corona virus disease-19 (COVID-19)
pharmacovigilance process
serious adverse drug reaction
Farmacia
topic adverse (side) effects
adverse drug reaction
corona virus disease-19 (COVID-19)
pharmacovigilance process
serious adverse drug reaction
Farmacia
description BACKGROUND: From March to April 2020, Spain was the center of the SARS-CoV-2 pandemic, particularly Madrid with approximately 30% of the cases in Spain. The aim of this study is to report the suspected serious adverse drug reactions (SADRs) in COVID-19 patients vs. non-COVID-19 patients detected by the prospective pharmacovigilance program based on automatic laboratory signals (ALSs) in the hospital (PPLSH) during that period. We also compared the results with the suspected SADRs detected during the same period for 2019. METHODS: All ALSs that reflected potential SADRs including neutropenia, pancytopenia, thrombocytopenia, anemia, eosinophilia, leukocytes in cerebrospinal fluid, hepatitis, pancreatitis, acute kidney injury, rhabdomyolysis, and hyponatremia were prospectively monitored in hospitalized patients during the study periods. We analyzed the incidence and the distribution of causative drugs for the COVID-19 patients. RESULTS: The incidence rate of SADRs detected in the COVID-19 patients was 760.63 (95% CI 707.89–816.01) per 10,000 patients, 4.75-fold higher than the SADR rate for non-COVID-19 patients (160.15 per 10,000 patients, 95% CI 137.09–186.80), and 5.84-fold higher than the SADR rate detected for the same period in 2019 (130.19 per 10,000 patients, 95% CI 109.53–154.36). The most frequently related drugs were tocilizumab (59.84%), dexketoprofen (13.93%), azithromycin (8.43%), lopinavir-ritonavir (7.35%), dexamethasone (7.62%), and chloroquine/hydroxychloroquine (6.91%). CONCLUSIONS: The incidence rate of SADRs detected by the PPSLH in patients with COVID-19 was 4.75-fold higher than that of the non-COVID-19 patients. Caution is recommended when using medications for COVID-19 patients, especially drugs that are hepatotoxic, myotoxic, and those that induce thromboembolic events.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020-12-03
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10486/695720
https://dx.doi.org/10.3389/fphar.2020.602841
url http://hdl.handle.net/10486/695720
https://dx.doi.org/10.3389/fphar.2020.602841
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Frontiers Media
publisher.none.fl_str_mv Frontiers Media
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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