PropertyValue
?:abstract
  • 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40264-020-01000-8) contains supplementary material, which is available to authorized users.
?:creator
?:doi
  • 10.1007/s40264-020-01000-8
?:doi
?:journal
  • Drug_Saf
?:license
  • cc-by-nc
?:pdf_json_files
  • document_parses/pdf_json/316cc38a1d61bc8a1221b2ad22664c276041cf15.json
?:pmc_json_files
  • document_parses/pmc_json/PMC7518652.xml.json
?:pmcid
?:pmid
?:pmid
  • 32978702.0
?:publication_isRelatedTo_Disease
?:sha_id
?:source
  • Medline; PMC
?:title
  • Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports
?:type
?:year
  • 2020-09-25

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