Safety of Drugs Used during the First Wave of COVID-19 : A Hospital-Registry-Based Study
Aguilera, Cristina (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Danés Carreras, Immaculada (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Guillén, Elena (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Vimes, Alba (Hospital Universitari Vall d'Hebron)
Bosch Ferrer, Montserrat (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Cereza García, Gloria (Hospital Universitari Vall d'Hebron)
Sánchez-Montalvá, Adrián (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Campos Varela, Isabel (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas)
Miarons, Marta (Hospital Universitari Vall d'Hebron)
Mestre Torres, Jaume (Hospital Universitari Vall d'Hebron)
Agustí Escasany, M. Antònia (Hospital Universitari Vall d'Hebron. Institut de Recerca)

Date:	2022
Abstract:	The emergency of the coronavirus disease 2019 (COVID-19) pandemic led to the off-label use of drugs without data on their toxicity profiles in patients with COVID-19, or on their concomitant use. Patients included in the COVID-19 Patient Registry of a tertiary hospital during the first wave were analyzed to evaluate the adverse drug reactions (ADRs) with the selected treatments. Twenty-one percent of patients (197 out of 933) had at least one ADR, with a total of 240 ADRs. Patients with ADRs were more commonly treated with multiple drugs for COVID-19 infection than patients without ADRs (p < 0. 001). They were younger (median 62 years vs. 70. 1 years; p < 0. 001) and took less medication regularly (69. 5% vs. 75. 7%; p = 0. 031). The most frequent ADRs were gastrointestinal (67. 1%), hepatobiliary (10. 8%), and cardiac disorders (3. 3%). Drugs more frequently involved included lopinavir/ritonavir (82. 2%), hydroxychloroquine (72. 1%), and azithromycin (66. 5%). Although most ADRs recovered without sequelae, fatal cases were described, even though the role of the disease could not be completely ruled out. In similar situations, efforts should be made to use the drugs in the context of clinical trials, and to limit off-label use to those drugs with a better benefit/risk profile in specific situations and for patients at high risk of poor disease prognosis.
Grants:	Instituto de Salud Carlos III JE18/00022 Instituto de Salud Carlos III PI19/00330
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Diagnostics, Vol. 12 Núm. 7 (july 2022) , p. 1612, ISSN 2075-4418

DOI: 10.3390/diagnostics12071612
PMID: 35885517

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