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..

Medienart:	E-Artikel

Erscheinungsjahr:	2020
Erschienen:	2020

Enthalten in:	Zur Gesamtaufnahme - volume:43
Enthalten in:	Drug safety - 43(2020), 12 vom: 25. Sept., Seite 1309-1314

Sprache:	Englisch

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

Links:	Volltext [kostenfrei]

BKL:	44.40$jPharmazie$jPharmazeutika

Anmerkungen:	© The Author(s) 2020

doi:	10.1007/s40264-020-01000-8

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	OLC212148115X