Article Text

Download PDFPDF
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report
  1. Fátima Falcão1,2,3,
  2. Erica Viegas2,3,4,
  3. Ines Carmo4,
  4. Joana Soares4,
  5. Margarida Falcao5,
  6. Mariana Solano4,
  7. Patricia Cavaco4,
  8. Dina Mendes5,
  9. João Rijo5,
  10. Pedro Povoa6,7,
  11. Antonio Pais Martins8,
  12. Eduarda Carmo9,
  13. Kamal Mansinho7,10,
  14. Candida Fonseca7,11,
  15. Luis Campos7,11,
  16. António Carvalho3,11,
  17. Ana Mirco2,3,
  18. Helena Farinha2,3,5,
  19. Isabel Aldir3,7,10,
  20. José Correia3
  1. 1 Pharmacy, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  2. 2 Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal
  3. 3 Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  4. 4 Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  5. 5 Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  6. 6 Polyvalent Intensive Care Unit, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  7. 7 Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal
  8. 8 Surgical Intensive Care Unit. Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  9. 9 Polyvalent Intensive Care Unit. Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  10. 10 Infecciology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  11. 11 Internal Medicine, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal
  1. Correspondence to Professor Fátima Falcão, Pharmacy, Centro Hospitalar de Lisboa Ocidental EPE, Lisboa 1449-005, Portugal; mffalcao{at}chlo.min-saude.pt

Abstract

Objectives Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM.

Methods An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts.

Results The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible.

Conclusions Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.

  • COVID-19
  • drug-related side effects and adverse reactions
  • drug monitoring
  • pharmacy service
  • hospital
  • clinical medicine

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

View Full Text