Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS)
Background: The in-hospital treatment for COVID-19 may include medicines from various therapeutic classes, such as antiviral remdesivir and immunosuppressant tocilizumab. Safety data for these medicines are based on controlled clinical trials and case reports, limiting the knowledge about less frequ...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1349543/full |
| _version_ | 1797333578246258688 |
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| author | Beatriz Marinho Silva Romão Felipe Vieira Duval Elisângela Costa Lima Fabrício Alves Barbosa da Silva Guacira Correa de Matos |
| author_facet | Beatriz Marinho Silva Romão Felipe Vieira Duval Elisângela Costa Lima Fabrício Alves Barbosa da Silva Guacira Correa de Matos |
| author_sort | Beatriz Marinho Silva Romão |
| collection | DOAJ |
| description | Background: The in-hospital treatment for COVID-19 may include medicines from various therapeutic classes, such as antiviral remdesivir and immunosuppressant tocilizumab. Safety data for these medicines are based on controlled clinical trials and case reports, limiting the knowledge about less frequent, rare or unique population adverse events excluded from clinical trials.Objective: This study aims at analyzing the reports of Adverse Drug Events (ADEs) related to these two medicines, focusing on events in pregnant women and foetuses.Methods: Data from the open-access FDA Adverse Event Reporting System (FAERS) from 2020 to 2022 were used to create a dashboard on the Grafana platform to ease querying and analyzing report events. Potential safety signals were generated using the ROR disproportionality measure.Results: Remdesivir was notified as the primary suspect in 7,147 reports and tocilizumab in 19,602. Three hundred and three potential safety signals were identified for remdesivir, of which six were related to pregnant women and foetuses (including abortion and foetal deaths). Tocilizumab accumulated 578 potential safety signals, and three of them were associated with this population (including neonatal death).Discussion: None of the possible signals generated for this population were found in the product labels. According to the NIH and the WHO protocols, both medicines are recommended for pregnant women hospitalized with COVID-19.Conclusion: Despite the known limitations of working with open data from spontaneous reporting systems (e.g., absence of certain clinical data, underreporting, a tendency to report severe events and recent medicines) and disproportionality analysis, the findings suggest concerning associations that need to be confirmed or rejected in subsequent clinical studies. |
| first_indexed | 2024-03-08T08:06:58Z |
| format | Article |
| id | doaj.art-debfa8d22c39452d9d73880c7e792f46 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-08T08:06:58Z |
| publishDate | 2024-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-debfa8d22c39452d9d73880c7e792f462024-02-02T10:38:10ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122024-01-011510.3389/fphar.2024.13495431349543Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS)Beatriz Marinho Silva Romão0Felipe Vieira Duval1Elisângela Costa Lima2Fabrício Alves Barbosa da Silva3Guacira Correa de Matos4Observatory of Medicines Surveillance and Use, Pharmacy School, Federal University of Rio de Janeiro, Rio de Janeiro, BrazilElectric Power Research Center, Rio de Janeiro, BrazilObservatory of Medicines Surveillance and Use, Pharmacy School, Federal University of Rio de Janeiro, Rio de Janeiro, BrazilScientific Computing Program, Oswaldo Cruz Foundation, Rio de Janeiro, BrazilObservatory of Medicines Surveillance and Use, Pharmacy School, Federal University of Rio de Janeiro, Rio de Janeiro, BrazilBackground: The in-hospital treatment for COVID-19 may include medicines from various therapeutic classes, such as antiviral remdesivir and immunosuppressant tocilizumab. Safety data for these medicines are based on controlled clinical trials and case reports, limiting the knowledge about less frequent, rare or unique population adverse events excluded from clinical trials.Objective: This study aims at analyzing the reports of Adverse Drug Events (ADEs) related to these two medicines, focusing on events in pregnant women and foetuses.Methods: Data from the open-access FDA Adverse Event Reporting System (FAERS) from 2020 to 2022 were used to create a dashboard on the Grafana platform to ease querying and analyzing report events. Potential safety signals were generated using the ROR disproportionality measure.Results: Remdesivir was notified as the primary suspect in 7,147 reports and tocilizumab in 19,602. Three hundred and three potential safety signals were identified for remdesivir, of which six were related to pregnant women and foetuses (including abortion and foetal deaths). Tocilizumab accumulated 578 potential safety signals, and three of them were associated with this population (including neonatal death).Discussion: None of the possible signals generated for this population were found in the product labels. According to the NIH and the WHO protocols, both medicines are recommended for pregnant women hospitalized with COVID-19.Conclusion: Despite the known limitations of working with open data from spontaneous reporting systems (e.g., absence of certain clinical data, underreporting, a tendency to report severe events and recent medicines) and disproportionality analysis, the findings suggest concerning associations that need to be confirmed or rejected in subsequent clinical studies.https://www.frontiersin.org/articles/10.3389/fphar.2024.1349543/fullpharmacovigilancedata miningadverse drug eventsFAERSCOVID-19pregnancy complications |
| spellingShingle | Beatriz Marinho Silva Romão Felipe Vieira Duval Elisângela Costa Lima Fabrício Alves Barbosa da Silva Guacira Correa de Matos Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) Frontiers in Pharmacology pharmacovigilance data mining adverse drug events FAERS COVID-19 pregnancy complications |
| title | Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) |
| title_full | Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) |
| title_fullStr | Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) |
| title_full_unstemmed | Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) |
| title_short | Detection of potential safety signals related to the use of remdesivir and tocilizumab in the COVID era during pregnancy, resorting to open data from the FDA adverse event reporting system (FAERS) |
| title_sort | detection of potential safety signals related to the use of remdesivir and tocilizumab in the covid era during pregnancy resorting to open data from the fda adverse event reporting system faers |
| topic | pharmacovigilance data mining adverse drug events FAERS COVID-19 pregnancy complications |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1349543/full |
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