ArticleDrug safety2016
Signal of Gastrointestinal Congenital Malformations with Antipsychotics After Minimising Competition Bias: A Disproportionality Analysis Using Data from Vigibase(®).
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.European journal of clinical pharmacology · 2025Pooled it
- Is Antipsychotic Drug Use During Pregnancy Associated with Increased Malformation Rates and Worsening of Maternal and Infant Outcomes? A Systematic Review.Current neuropharmacology · 2024Pooled it
- Evaluating COVID-19 Vaccine Masking and Unmasking Methods in Two National Pharmacovigilance Databases.Drug safety · 2026Article
- Dopamine Partial Agonists in Pregnancy and Lactation: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Postmarketing adverse events associated with onasemnogene abeparvovec: a real-world pharmacovigilance study.Orphanet journal of rare diseases · 2025Article
- A real-world pharmacovigilance analysis of omadacycline in FDA adverse event reporting system (FAERS) database.Frontiers in pharmacology · 2025Article
- An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance.Drug safety · 2023Article
- Association of In Utero Antipsychotic Medication Exposure With Risk of Congenital Malformations in Nordic Countries and the US.JAMA psychiatry · 2023Article
- Cholinesterase inhibitors-associated torsade de pointes/QT prolongation: a real-world pharmacovigilance study.Frontiers in pharmacology · 2023Article
- Article
- Article
- A stratification method based on clustering for the minimization of data masking effect in signal detection.BMC medical informatics and decision making · 2020Article
- Atypical antipsychotic use during pregnancy and birth defect risk: National Birth Defects Prevention Study, 1997-2011.Schizophrenia research · 2020Article
- Safe Expectations: Current State and Future Directions for Medication Safety in Pregnancy Research.Clinical therapeutics · 2019Article
- Use of Antipsychotic Drugs During Pregnancy.Current treatment options in psychiatry · 2019Article
- Observational
- A mathematical framework to quantify the masking effect associated with the confidence intervals of measures of disproportionality.Therapeutic advances in drug safety · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInvestigations have highlighted the lack of evidence regarding the likelihood of congenital malformations following exposure to antipsychotic drugs during pregnancy. To gain further knowledge regarding their safety, we evaluated signals of congenital malformations with antipsychotics using VigiBase(®), the World Health Organization (WHO) Global Individual Case Safety Report (ICSR) database.
methodA case/non-case study was conducted in VigiBase(®) between 1967 and 2014. Signals of disproportionate reporting (SDRs) were detected using the proportional reporting ratio (PRR), which defines SDRs as drug-report associations with a PRR ≥2, Chi square ≥4, and number of cases ≥3. SDR detection for antipsychotics was performed for congenital malformations after removing all reports related to drug competitors and reports of movement disorders from the database.
resultsAfter removing reports related to drug competitors (antiepileptics, antidepressants, antivirals) and movement disorders, three signals were revealed: 'palate disorders congenital' (PRR 2.1, 95 % CI 1.6-2.9, Chi square = 30; n = 41), 'oesophageal disorders congenital' (PRR 2.5, 95 % CI 1.3-4.7, Chi square = 11; n = 10) and 'anorectal disorders congenital' (PRR 3.0, 95 % CI 1.6-5.6, Chi square = 13; n = 11). Among antipsychotics, phenothiazines with a piperazine side-chain, risperidone and aripiprazole appeared to be more suspect.
conclusionConfirming a first signal from spontaneous reporting data, three SDRs for antipsychotics and gastrointestinal congenital abnormalities were unmasked in VigiBase(®). This signal should be further explored by ad hoc pharmacoepidemiologic studies in order to assess whether it is relevant for prescription and public health.
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