Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases

Simple item page
dc.contributor.authorKhan, Zakir
dc.contributor.authorDoherty, Ann Sinéad
dc.contributor.authorMcCarthy, Caroline
dc.contributor.authorDalton, Kieran
dc.contributor.authorJungo, Katharina Tabea
dc.contributor.authorReeve, Emily
dc.contributor.authorMoriarty, Frank
dc.contributor.funderEuropean Commission
dc.date.accessioned2026-09-09T11:29:01Z
dc.date.available2026-09-09T11:29:01Z
dc.date.issued2026-08-06
dc.description.abstractBackground: Adverse drug withdrawal events (ADWEs) are a key safety concern with deprescribing but are infrequently reported in trials. Although pharmacovigilance systems have advanced understanding of medication-related harms, it is unclear how extensively these systems have been used for ADWEs. This study aimed to examine the reporting patterns of ADWEs for all drugs recorded in United States and European pharmacovigilance databases between 2004 and 2023. Methods: A retrospective study was conducted using two pharmacovigilance databases, the publicly available FDA-FAERS dataset and EMA-EV Level 2 A (individual-level) dataset. ADWE cases were identified using relevant MedDRA preferred terms. Data on patient characteristics, reporter type, drugs, indication, ADWE outcomes, dechallenge/rechallenge, seriousness criteria, time to onset, duration, and causality were summarised. Results: A total of 158,505 ADWE reports were analysed (FDA-FAERS: 145,514; EMA-EV: 12,987), with mean ages of 46.1 ± 17.8 (FDA; 55.3% female) and 45.5 ± 21.9 years (EMA; 57.1% female). The frequently reported drug classes were opioids (FDA: oxycodone, 29.8%; EMA: buprenorphine, 19%), antidepressants (FDA: duloxetine, 32%; EMA: venlafaxine, 25.9%) and gabapentinoids (FDA: pregabalin, 6.7%; EMA: pregabalin, 6.0%). The most common adverse outcomes were other serious medical conditions (FDA = 63.9%; EMA = 46.0%), hospitalisation (FDA = 15.9%; EMA = 28.3%), and disability (FDA = 13.3%; EMA = 6.2%) and these outcomes varied significantly based on sex and age group (p < 0.05). Conclusions: This study provides novel evidence of reporting patterns and characteristics of ADWEs across drugs in pharmacovigilance data. These findings emphasise that adverse drug reaction reporting systems need to accommodate ADWEs (i.e., clarity on terminologies, dechallenge/rechallenge, causality assessment) to effectively capture ADWE-related data to support evidence-based deprescribing practices for better patient safety.en
dc.description.sponsorshipEuropean Commission| 101149577|HEAD-P
dc.description.versionPublished Version
dc.format.extent12
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid100828
dc.identifier.authororcidKhan, Zakir
dc.identifier.authororcidDoherty, Ann Sinéad
dc.identifier.authororcidMcCarthy, Caroline
dc.identifier.authororcidDalton, Kieran§0000-0003-1209-8079
dc.identifier.authororcidJungo, Katharina Tabea
dc.identifier.authororcidReeve, Emily
dc.identifier.authororcidMoriarty, Frank
dc.identifier.citationKhan, Z, Doherty, A S, McCarthy, C, Dalton, K, Jungo, K T, Reeve, E & Moriarty, F 2026, 'Reporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databases', Exploratory Research in Clinical and Social Pharmacy, vol. 23, 100828, pp. 1-12. https://doi.org/10.1016/j.rcsop.2026.100828
dc.identifier.doi10.1016/j.rcsop.2026.100828
dc.identifier.endpage12
dc.identifier.issn2667-2766
dc.identifier.journaltitleExploratory Research in Clinical and Social Pharmacy
dc.identifier.otherORCID: /0000-0003-1209-8079/work/226277214
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19207
dc.identifier.volume23
dc.language.isoen
dc.publisherElsevier Inc.
dc.relation.urihttps://www.scopus.com/pages/publications/105046456376
dc.rights© 2026, the Authors. Published by Elsevier Inc. This is an open access article under the CC BY license. http://creativecommons.org/licenses/by/4.0/
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.statusPeer reviewed
dc.subjectAdverse drug withdrawal reactions
dc.subjectDeprescribing
dc.subjectEMA
dc.subjectFDA
dc.subjectMedication harms
dc.subjectPharmacovigilance
dc.subject[Medicine]
dc.subject[Dental]
dc.subject[Pharmacy]
dc.titleReporting patterns of adverse drug withdrawal events using individual case safety reports in the FAERS and Eudravigilance databasesen
dc.typeArticle (peer-reviewed)
Files
Original bundle
Now showing 1 - 2 of 2
Thumbnail Image
Name:
1-s2.0-S2667276626001265-main.pdf
Size:
2.2 MB
Format:
Adobe Portable Document Format
Description:
Published Version
Download
Thumbnail Image
Name:
Supplementary_Data.zip
Size:
371.26 KB
Format:
http://www.iana.org/assignments/media-types/application/zip
Description:
Suppplementary Data
Download
Collections
School of Pharmacy
Cork University Dental School and Hospital
School of Medicine