ArticleEuropean journal of clinical pharmacology2021
Second-generation antipsychotic use during pregnancy and risk of congenital malformations.
Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.
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The trial behind it
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Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Antipsychotic drug use during pregnancy and neonatal outcomes: a systematic review and meta-analysis.Archives of women's mental health · 2026Pooled it
- Pooled 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
- Place of the partial dopamine receptor agonist aripiprazole in the management of schizophrenia in adults: a Delphi consensus study.BMC psychiatry · 2022Pooled it
- Article
- Comparative modelling of foetal exposure to maternal long-acting injectable versus oral daily antipsychotics.npj women's health · 2025Article
- Real-world pharmacovigilance study on neonatal congenital anomalies associated with maternal drug exposure using the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Are congenital malformations associated with maternal sociodemographic and risk factors? A multicenter ultrasound-based study.Pakistan journal of medical sciences · 2024Article
- Risk of congenital malformations associated with first-trimester exposure to antipsychotics: A propensity score-weighted population-based cohort study.European psychiatry : the journal of the Association of European Psychiatrists · 2024Article
- Outcomes of long-acting injectable antipsychotics use in pregnancy: A literature review.World journal of psychiatry · 2024Article
- Striking the Balance: Bipolar Disorder in the Perinatal Period.Focus (American Psychiatric Publishing) · 2024Review
- Concepts for selection and utilization of psychiatric medications in pregnancy.The mental health clinician · 2023Article
- [Psychopharmacotherapy during pregnancy and breastfeeding-Part I: focus on pregnancy : Support options by using therapeutic drug monitoring].Der Nervenarzt · 2023Review
- Psychiatric Treatment in Pregnancy: A Narrative Review.Journal of clinical medicine · 2023Review
- Antipsychotic utilization patterns in pregnant women with psychotic disorders: a 16-year population-based cohort study.European archives of psychiatry and clinical neuroscience · 2023Article
- Association of In Utero Antipsychotic Medication Exposure With Risk of Congenital Malformations in Nordic Countries and the US.JAMA psychiatry · 2023Article
- Olanzapine Pharmacokinetics: A Clinical Review of Current Insights and Remaining Questions.Pharmacogenomics and personalized medicine · 2023Review
- Novel report on congenital talipes equinovarus (CTEV) following olanzapine exposure during pregnancy: case report and short review.Archives of women's mental health · 2022Article
- Antipsychotics during pregnancy and increased risk of congenital malformation in offspring: toward a systematic use of real-world data.The Lancet regional health. Europe · 2021Article
- Malformations and pregnancy with schizophrenia.The Lancet regional health. Europe · 2021Article
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo study if second-generation antipsychotic (S-GA) use during the first trimester of pregnancy is associated with an increased risk of major congenital malformations (MCM).
methodsA population-based birth cohort study using national register data extracted from the Drugs and Pregnancy database in Finland, years 1996-2017. The sampling frame included 1,273,987 pregnant women. We included singleton pregnancies ending in live or stillbirth or termination of pregnancy due to severe malformation. Pregnancies with exposure to known teratogens were excluded. Women were categorized into three groups: exposed to S-GAs (n = 3478), exposed to first-generation antipsychotics (F-GAs) (n = 1030), and unexposed (no purchases of S-GAs or F-GAs during pregnancy, n = 22,540). We excluded genetic conditions and compared the prevalence of MCMs in S-GA users to the two comparison groups using multiple logistic regression models.
resultsUse of S-GAs during early pregnancy was not associated with an increased risk of overall MCMs compared to unexposed (adjusted odds ratio, OR 0.92; 95% CI 0.72-1.19) or to F-GA users (OR 0.82; 95% CI 0.56-1.20). Of individual S-GAs, olanzapine use was associated with an increased risk of overall MCMs (OR 2.12; 95% CI 1.19-3.76), and specifically, an increased risk of musculoskeletal malformations (OR 3.71; 95% CI 1.35-10.1) when compared to unexposed, while comparisons to F-GA users did not show significant results.
conclusionsOlanzapine use is associated with an increased risk of major congenital malformations and specifically, musculoskeletal malformations. Use during pregnancy should be restricted to situations where no safer alternatives exist.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.