Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase
Pregnancy
Infant, Newborn
Female
Humans
Rituximab
/ therapeutic use
Abatacept
Biological Products
/ adverse effects
Interleukin 1 Receptor Antagonist Protein
/ therapeutic use
Pharmacovigilance
Autoimmune Diseases
/ drug therapy
World Health Organization
Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Journal
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
ISSN: 1179-190X
Titre abrégé: BioDrugs
Pays: New Zealand
ID NLM: 9705305
Informations de publication
Date de publication:
Jan 2023
Jan 2023
Historique:
accepted:
25
10
2022
pubmed:
20
11
2022
medline:
17
1
2023
entrez:
19
11
2022
Statut:
ppublish
Résumé
Published data on the safety of biologics other than tumor necrosis factor (TNF) inhibitors during pregnancy are limited. The aim was to detect pharmacovigilance signals for fetal and neonatal adverse drug reactions (ADRs) to biologics taken by pregnant women with autoimmune diseases. We performed a disproportionality analysis of the World Health Organization's VigiBase In the main analysis, the RORs were particularly high for musculoskeletal malformations with anakinra (7.18 [3.50-14.73]), canakinumab (19.54 [12.82-29.79]), and abatacept (5.09 [2.77-9.33]), and for immune system disorders with canakinumab (347.88 [217.9-555.50]) and rituximab (9.27 [2.95-29.15]). After the exclusion of reports with steroids, the ROR was significant for neonatal infections with belimumab (28.49 [5.75-141.25]). We identified possible associations with some adverse fetal and neonatal outcomes, suggesting that vigilance is required when prescribing certain biologics during pregnancy.
Identifiants
pubmed: 36401769
doi: 10.1007/s40259-022-00564-4
pii: 10.1007/s40259-022-00564-4
pmc: PMC9676840
doi:
Substances chimiques
Rituximab
4F4X42SYQ6
Abatacept
7D0YB67S97
Biological Products
0
Interleukin 1 Receptor Antagonist Protein
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
73-87Informations de copyright
© 2022. The Author(s).
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