Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports

INTRODUCTION: In late 2019, a new coronavirus-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-was discovered in Wuhan, China, and the World Health Organization later declared coronavirus disease 2019 (COVID-19) a pandemic. Numerous drugs have been repurposed and investigated for therapeutic effectiveness in the disease, including those from "Solidarity," an international clinical trial (azithromycin, chloroquine, hydroxychloroquine, the fixed combination lopinavir/ritonavir, and remdesivir).

OBJECTIVE: Our objective was to evaluate adverse drug reaction (ADR) reporting for drugs when used in the treatment of COVID-19 compared with use for other indications, specifically focussing on sex differences.

METHOD: We extracted reports on COVID-19-specific treatments from the global ADR database, VigiBase, using an algorithm developed to identify reports that listed COVID-19 as the indication. The Solidarity trial drugs were included, as were any drugs reported ≥ 100 times. We performed a descriptive comparison of reports for the same drugs used in non-COVID-19 indications. The data lock point date was 7 June 2020.

RESULTS: In total, 2573 reports were identified for drugs used in the treatment of COVID-19. In order of frequency, the most reported ADRs were electrocardiogram QT-prolonged, diarrhoea, nausea, hepatitis, and vomiting in males and diarrhoea, electrocardiogram QT-prolonged, nausea, vomiting, and upper abdominal pain in females. Other hepatic and kidney-related events were included in the top ten ADRs in males, whereas no hepatic or renal terms were reported for females. COVID-19-related reporting patterns differed from non-pandemic reporting for these drugs.

CONCLUSION: Review of a global database of suspected ADR reports revealed sex differences in the reporting patterns for drugs used in the treatment of COVID-19. Patterns of ADR sex differences need further elucidation.

Errataetall:

CommentIn: Drug Saf. 2021 Feb;44(2):255-257. - PMID 33245507

Medienart:

E-Artikel

Erscheinungsjahr:

2020

Erschienen:

2020

Enthalten in:

Zur Gesamtaufnahme - volume:43

Enthalten in:

Drug safety - 43(2020), 12 vom: 25. Dez., Seite 1309-1314

Sprache:

Englisch

Beteiligte Personen:

Zekarias, Alem [VerfasserIn]
Watson, Sarah [VerfasserIn]
Vidlin, Sara Hedfors [VerfasserIn]
Grundmark, Birgitta [VerfasserIn]

Links:

Volltext

Themen:

20O93L6F9H
2494G1JF75
3QKI37EEHE
415SHH325A
4QWG6N8QKH
83905-01-5
886U3H6UFF
Adenosine Monophosphate
Alanine
Antibodies, Monoclonal, Humanized
Antiviral Agents
Azithromycin
Chloroquine
Drug Combinations
Hydroxychloroquine
I031V2H011
Journal Article
Lopinavir
Lopinavir-ritonavir drug combination
O3J8G9O825
OF5P57N2ZX
Oseltamivir
Remdesivir
Ritonavir
Tocilizumab

Anmerkungen:

Date Completed 11.12.2020

Date Revised 07.12.2022

published: Print-Electronic

CommentIn: Drug Saf. 2021 Feb;44(2):255-257. - PMID 33245507

Citation Status MEDLINE

doi:

10.1007/s40264-020-01000-8

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM31549428X