PMID- 37269915
OWN - NLM
STAT- MEDLINE
DCOM- 20230703
LR  - 20231205
IS  - 1873-1708 (Electronic)
IS  - 0890-6238 (Linking)
VI  - 119
DP  - 2023 Aug
TI  - Use of proton pump inhibitors during pregnancy: A systematic review and 
      meta-analysis of congenital malformations.
PG  - 108419
LID - S0890-6238(23)00093-X [pii]
LID - 10.1016/j.reprotox.2023.108419 [doi]
AB  - Use of proton pump inhibitors (PPI) are common among pregnant women to relieve 
      gastrointestinal symptoms. The number of exposed pregnancies is therefore 
      considerable, and a recent meta-analysis (MA) from 2020 raised concern about 
      their teratogenicity. The aim of the study was to provide a MA of the risk of 
      major congenital malformations (MCM) after PPI exposure during the first 
      trimester of pregnancy. A systematic review and random-effects model approach 
      were performed using a collaborative WEB-based meta-analysis platform 
      (metaPreg.org) with a registered protocol (osf.io/u4gva). The primary outcome was 
      the incidence of overall MCM. The secondary outcomes of interest were specific 
      MCM reported by at least three studies. All comparative studies assessing these 
      outcomes in PPI exposed pregnancies were searched from inception to April 2022. 
      From the 211 initially identified studies, 11 were included in the MA. The pooled 
      odds ratio (OR) for the primary outcome showed no significant results based on 5 
      618 exposed pregnancies (OR 1.10, 95% CI [0.95;1.26]; I(2)=0%). Similarly, no 
      result was significant for the secondary outcomes. The total exposed sample size 
      ranged from 3 161-5 085; OR ranged between 0.60 and 1.92; heterogeneity was 
      between 0% and 23%. Based on the results of the present MA, first trimester PPI 
      exposure was not associated with a significantly increased risk of overall or 
      specific MCM. However, this MA included only observational studies which are 
      prone to bias and there were insufficient data to evaluate PPI at a substance 
      level. Future studies are needed to address this concern.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Peron, Audrey
AU  - Peron A
AD  - Service Hospitalo-Universitaire de Pharmaco-Toxicologie, Hospices Civils de Lyon, 
      Lyon, France. Electronic address: audrey.peron@metapreg.org.
FAU - Ripoche, Emmanuelle
AU  - Ripoche E
AD  - Adverse Events and Incidents Department-Surveillance Division, Agence nationale 
      de securite du medicament et des produits de sante (ANSM), Saint Denis, France.
FAU - Picot, Cyndie
AU  - Picot C
AD  - Service Hospitalo-Universitaire de Pharmaco-Toxicologie, Hospices Civils de Lyon, 
      Lyon, France.
FAU - Ajiji, Priscilla
AU  - Ajiji P
AD  - Adverse Events and Incidents Department-Surveillance Division, Agence nationale 
      de securite du medicament et des produits de sante (ANSM), Saint Denis, France; 
      EA 7379, Faculte de Sante, Universite Paris-Est Creteil, France.
FAU - Cucherat, Michel
AU  - Cucherat M
AD  - Service Hospitalo-Universitaire de Pharmaco-Toxicologie, Hospices Civils de Lyon, 
      Lyon, France; CNRS-Universite Lyon 1, UMR5558 - Laboratoire de Biometrie & 
      biologie evolutive, Departement de biostatistiques & modelisation pour la sante 
      et l'environnement-Equipe Evaluation et modelisation des effets des medicaments, 
      Lyon, France.
FAU - Cottin, Judith
AU  - Cottin J
AD  - Service Hospitalo-Universitaire de Pharmaco-Toxicologie, Hospices Civils de Lyon, 
      Lyon, France.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20230602
PL  - United States
TA  - Reprod Toxicol
JT  - Reproductive toxicology (Elmsford, N.Y.)
JID - 8803591
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Pregnancy
MH  - Humans
MH  - Female
MH  - *Proton Pump Inhibitors/adverse effects
MH  - Pregnancy Trimester, First
MH  - *Teratogenesis
OTO - NOTNLM
OT  - Congenital malformations
OT  - Meta-analysis
OT  - Pregnancy
OT  - Proton pump inhibitors
OT  - ROBINS-I
OT  - Systematic review
COIS- Declaration of Competing Interest The authors have indicated they have no 
      potential conflicts of interest to disclose. This research did receive a specific 
      grant from the French National Agency for the Safety of Medicines and Health 
      Products.
EDAT- 2023/06/04 01:08
MHDA- 2023/07/03 06:41
CRDT- 2023/06/03 19:22
PHST- 2022/12/30 00:00 [received]
PHST- 2023/05/14 00:00 [revised]
PHST- 2023/05/31 00:00 [accepted]
PHST- 2023/07/03 06:41 [medline]
PHST- 2023/06/04 01:08 [pubmed]
PHST- 2023/06/03 19:22 [entrez]
AID - S0890-6238(23)00093-X [pii]
AID - 10.1016/j.reprotox.2023.108419 [doi]
PST - ppublish
SO  - Reprod Toxicol. 2023 Aug;119:108419. doi: 10.1016/j.reprotox.2023.108419. Epub 
      2023 Jun 2.