Safety of clozapine use during pregnancy: Analysis of international pharmacovigilance data.
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Antipsychotic Agents
/ adverse effects
Child
Clozapine
/ adverse effects
Databases, Factual
Female
Humans
Middle Aged
Pharmacovigilance
Pregnancy
Pregnancy Complications
/ chemically induced
Risk Assessment
Risk Factors
Schizophrenia
/ diagnosis
Young Adult
clozapine
pharmacoepidemiology
pharmacovigilance
pregnancy
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
14
11
2019
revised:
11
03
2020
accepted:
06
04
2020
pubmed:
8
5
2020
medline:
22
4
2021
entrez:
8
5
2020
Statut:
ppublish
Résumé
Safety data on clozapine use during pregnancy are limited. The aim of this study was to determine disproportionality in case safety reports on adverse pregnancy outcomes between clozapine and other antipsychotics (OAP) used during pregnancy. We included all reports of suspected adverse drug reactions (ADRs) to antipsychotics registered in the World Health Organization global individual case safety report (ICSR) database (VigiBase) in children younger than 2 years and women aged 12-45 years. A case/non-case approach was used to evaluate the association between several pregnancy-related ADRs and clozapine exposure during pregnancy, using 2×2 contingency tables to investigate disproportionality and Standard MedDRA Queries to select cases. Clozapine exposure was defined as all ICSR-ADR combinations with clozapine as (one of) the suspected drug(s). Non-exposure was defined as all ICSR-ADR combinations with OAP as (one of) the suspected drug(s). We identified 42 236 unique ICSR-ADR combinations related with clozapine exposure and 170 710 with OAP exposure. Of these, 494 and 4645 ICSR-ADR combinations involved adverse pregnancy outcomes related with clozapine exposure and OAP exposure respectively. Overall, no signal of disproportionate reporting associating clozapine with the studied adverse pregnancy outcomes was found compared with OAP exposure. Based on global pharmacovigilance data, we did not find any evidence that clozapine is less safe during pregnancy than OAP. Although this is not automatically equivalent to the relative safety of clozapine during pregnancy, these findings add to the convergence of proofs to allow final conclusions and decisions regarding the treatment of pregnant women with clozapine.
Substances chimiques
Antipsychotic Agents
0
Clozapine
J60AR2IKIC
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
725-735Informations de copyright
© 2020 John Wiley & Sons Ltd.
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