<strong>Suspected Serious Adverse Drug Reactions in Hospitalized COVID-19 Patients</strong>

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 versus 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&amp;ndash;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&amp;ndash;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&amp;ndash;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.

Comment on ‘Drug reaction with eosinophilia and systemic symptoms syndrome in a patient with COVID‐19’: involvement of herpesvirus reactivations and adverse drug reactions in diverse cutaneous manifestations and overall disease severity of COVID‐19

“…In addition, adverse drug reactions (ADRs) could have contributed to the diverse cutaneous manifestations. In support of this, a recent report describe 5.84-fold higher incidence rate of severe ADRs in COVID-19 patients; 9 and we have recently reported a COVID-19 patient who developed typical COVID-19-associated cutaneous manifestations, 10 symmetrical drug-related intertriginous and flexural exanthema, in which 'multiple drug hypersensitivity' not only to the causative drug but also to other drugs used for COVID-19 was demonstrated by lymphocyte transformation tests. 10 Such 'multiple drug hypersensitivity' was typically observed in the acute~subacute phases of DiHS/DRESS, at which time Treg function becomes impaired.…”