Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference

Introduction Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications. Aims This study aimed to identify signals of potentially...

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Autores: Cavadino A, Sandberg L, Öhman I, Bergvall T, Star K, Dolk H, Loane M, Addor MC, Barisic I, Cavero-Carbonell C, Garne E, Gatt M, Khoshnood B, Klungsøyr K, Latos-Bielenska A, Lelong N, Lutke R, Materna-Kiryluk A, Nelen V, Nevill A, O'Mahony M, Mokoroa O, Pierini A, Randrianaivo H, Rissmann A, Tucker D, Wiesel A, Yevtushok L, Morris JK
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p9430
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/9430
Access Level:acceso abierto
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spelling Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of ReferenceCavadino ASandberg LÖhman IBergvall TStar KDolk HLoane MAddor MCBarisic ICavero-Carbonell CGarne EGatt MKhoshnood BKlungsøyr KLatos-Bielenska ALelong NLutke RMaterna-Kiryluk ANelen VNevill AO'Mahony MMokoroa OPierini ARandrianaivo HRissmann ATucker DWiesel AYevtushok LMorris JKIntroduction Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications. Aims This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals. Methods Signals of medication-congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation. Results EUROmediCAT analysis identified 49 signals of medication-congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly. Conclusion EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.ADIS INT LTD2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/9430DRUG SAFETYISSN: 01145916ISSNe: 11791942reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p94302026-06-11T12:45:17Z
dc.title.none.fl_str_mv Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
title Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
spellingShingle Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
Cavadino A
title_short Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
title_full Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
title_fullStr Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
title_full_unstemmed Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
title_sort Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
dc.creator.none.fl_str_mv Cavadino A
Sandberg L
Öhman I
Bergvall T
Star K
Dolk H
Loane M
Addor MC
Barisic I
Cavero-Carbonell C
Garne E
Gatt M
Khoshnood B
Klungsøyr K
Latos-Bielenska A
Lelong N
Lutke R
Materna-Kiryluk A
Nelen V
Nevill A
O'Mahony M
Mokoroa O
Pierini A
Randrianaivo H
Rissmann A
Tucker D
Wiesel A
Yevtushok L
Morris JK
author Cavadino A
author_facet Cavadino A
Sandberg L
Öhman I
Bergvall T
Star K
Dolk H
Loane M
Addor MC
Barisic I
Cavero-Carbonell C
Garne E
Gatt M
Khoshnood B
Klungsøyr K
Latos-Bielenska A
Lelong N
Lutke R
Materna-Kiryluk A
Nelen V
Nevill A
O'Mahony M
Mokoroa O
Pierini A
Randrianaivo H
Rissmann A
Tucker D
Wiesel A
Yevtushok L
Morris JK
author_role author
author2 Sandberg L
Öhman I
Bergvall T
Star K
Dolk H
Loane M
Addor MC
Barisic I
Cavero-Carbonell C
Garne E
Gatt M
Khoshnood B
Klungsøyr K
Latos-Bielenska A
Lelong N
Lutke R
Materna-Kiryluk A
Nelen V
Nevill A
O'Mahony M
Mokoroa O
Pierini A
Randrianaivo H
Rissmann A
Tucker D
Wiesel A
Yevtushok L
Morris JK
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
description Introduction Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications. Aims This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals. Methods Signals of medication-congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation. Results EUROmediCAT analysis identified 49 signals of medication-congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly. Conclusion EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/9430
url https://fisabio.portalinvestigacion.com/publicaciones/9430
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ADIS INT LTD
publisher.none.fl_str_mv ADIS INT LTD
dc.source.none.fl_str_mv DRUG SAFETY
ISSN: 01145916
ISSNe: 11791942
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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