Advances in Pharmacological and Pharmaceutical Sciences (Jan 2023)

Adverse Drug Reactions during COVID-19 Treatment: A Comprehensive Analysis Focused on Hospitalized Patients, with the Use of a Survey in Cuba in 2020

  • Lizette Gil-del-Valle,
  • Rosario Gravier-Hernández,
  • Waldemar Baldoquin-Rodríguez,
  • Beatriz Sierra-Vázquez,
  • Ana Beatriz Perez-Díaz,
  • Pablo Sariol-Resik,
  • Tatiana Prieto-Dominguez,
  • Mario Manuel Delgado-Guerra,
  • Joniel Arnoldo Sánchez- Márquez,
  • Olga Elena López-Fernández,
  • Faustina Fonseca-Betancourt,
  • Liana Valdés-Lanza,
  • Odalys Orraca-Castillo,
  • Xaveer Van Ostade,
  • Wim Vanden Berghe,
  • Veerle Vanlerberghe,
  • M. Guadalupe Guzmán-Tirado

DOI
https://doi.org/10.1155/2023/1995642
Journal volume & issue
Vol. 2023

Abstract

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Context. Off-label, compassionate use of potential drugs against SARS-CoV-2 acute infection could modify their safety profiles. Aims. To evaluate the prevalence and type of adverse drug reactions (ADRs), together with associated risk factors, among Cuban COVID-19 patients treated with chloroquine (CQ), lopinavir/ritonavir (LPV/r), or interferon α2b (IFN α2b), according to the Cuban protocol. Materials and Methods. A prospective descriptive analysis of ADRs was performed on 200 COVID-19 patients who were admitted consecutively to three hospitals in Havana and Pinar del Río from April to July 2020. Information on demographics, ADRs, outcomes, behavioral, and health-related factors was collected using a validated questionnaire and clinical records. Each potential ADR case was assessed for causality based on the WHO-UMC algorithm, concomitant drug influences, and the presence of any drug-drug interactions (DDI). Results. The total frequency of ADRs was 55%, with predominantly gastrointestinal disorders and general symptoms (23% vs 20%). 95.1% of ADRs occurred within 10 days after treatment and 42 potential DDI in 55.5% of patients (61/110) were observed. The prevalence of ADRs was: 44%, 30.4%, and 26.4% for IFN α2b, LPV/r, and CQ, respectively. Sex (odds ratio (OR): 0.40 (95% confidence interval (CI): 0.211–0.742), age (OR: 2.36 (95% CI: 1.02–5.44)), and underlying diseases (OR: 0.12 (95% CI: 0.06–0.23)) were independently associated factors for ADRs (P37 years old, and female sex were associated with ADRs.