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
Entity
UAM. Departamento de FarmacologíaPublisher
Frontiers MediaDate
2020-12-03Citation
10.3389/fphar.2020.602841
Frontiers in Pharmacology 11.Dec (2020): 602841
ISSN
1663-9812DOI
10.3389/fphar.2020.602841Editor's Version
https://doi.org/10.3389/fphar.2020.602841Subjects
adverse (side) effects; adverse drug reaction; corona virus disease-19 (COVID-19); pharmacovigilance process; serious adverse drug reaction; FarmaciaRights
2020 Ramírez, Urroz, Rodríguez, González-Muñoz,Martín-Vega, Villán, Seco, Monserrat, Frías, Carcas and Borobia.Abstract
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.
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Google Scholar:Ramírez García, Elena
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Urroz, Mikel
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Rodríguez, Amelia
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González-Muñoz, Miguel
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Martín-Vega, Alberto
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Villán, Yuri
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Seco, Enrique
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Monserrat, Jaime
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Frías Iniesta, Jesús A.
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Carcas Sansuán, Antonio Javier
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Borobia Pérez, Alberto M.
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