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] |
---|
Links: |
---|
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 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM31549428X | ||
003 | DE-627 | ||
005 | 20231225155034.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231225s2020 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s40264-020-01000-8 |2 doi | |
028 | 5 | 2 | |a pubmed24n1051.xml |
035 | |a (DE-627)NLM31549428X | ||
035 | |a (NLM)32978702 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Zekarias, Alem |e verfasserin |4 aut | |
245 | 1 | 0 | |a Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports |
264 | 1 | |c 2020 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 11.12.2020 | ||
500 | |a Date Revised 07.12.2022 | ||
500 | |a published: Print-Electronic | ||
500 | |a CommentIn: Drug Saf. 2021 Feb;44(2):255-257. - PMID 33245507 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a 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) | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
650 | 4 | |a Journal Article | |
650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
650 | 7 | |a Antiviral Agents |2 NLM | |
650 | 7 | |a Drug Combinations |2 NLM | |
650 | 7 | |a lopinavir-ritonavir drug combination |2 NLM | |
650 | 7 | |a Oseltamivir |2 NLM | |
650 | 7 | |a 20O93L6F9H |2 NLM | |
650 | 7 | |a Lopinavir |2 NLM | |
650 | 7 | |a 2494G1JF75 |2 NLM | |
650 | 7 | |a remdesivir |2 NLM | |
650 | 7 | |a 3QKI37EEHE |2 NLM | |
650 | 7 | |a Adenosine Monophosphate |2 NLM | |
650 | 7 | |a 415SHH325A |2 NLM | |
650 | 7 | |a Hydroxychloroquine |2 NLM | |
650 | 7 | |a 4QWG6N8QKH |2 NLM | |
650 | 7 | |a Azithromycin |2 NLM | |
650 | 7 | |a 83905-01-5 |2 NLM | |
650 | 7 | |a Chloroquine |2 NLM | |
650 | 7 | |a 886U3H6UFF |2 NLM | |
650 | 7 | |a tocilizumab |2 NLM | |
650 | 7 | |a I031V2H011 |2 NLM | |
650 | 7 | |a Ritonavir |2 NLM | |
650 | 7 | |a O3J8G9O825 |2 NLM | |
650 | 7 | |a Alanine |2 NLM | |
650 | 7 | |a OF5P57N2ZX |2 NLM | |
700 | 1 | |a Watson, Sarah |e verfasserin |4 aut | |
700 | 1 | |a Vidlin, Sara Hedfors |e verfasserin |4 aut | |
700 | 1 | |a Grundmark, Birgitta |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Drug safety |d 1993 |g 43(2020), 12 vom: 25. Dez., Seite 1309-1314 |w (DE-627)NLM013282689 |x 1179-1942 |7 nnns |
773 | 1 | 8 | |g volume:43 |g year:2020 |g number:12 |g day:25 |g month:12 |g pages:1309-1314 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40264-020-01000-8 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 43 |j 2020 |e 12 |b 25 |c 12 |h 1309-1314 |