SynthesisBritish journal of clinical pharmacology2016
The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis.
Synthesis in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Safety of psychotropic medications in pregnancy: an umbrella review.Molecular psychiatry · 2025Pooled it
- Benefits and Risks of Antidepressant Drugs During Pregnancy: A Systematic Review of Meta-analyses.Paediatric drugs · 2023Pooled it
- Maternal exposure to SSRIs or SNRIs and the risk of congenital abnormalities in offspring: A systematic review and meta-analysis.PloS one · 2023Pooled it
- A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants.Drug safety · 2021Pooled it
- Association of Antidepressant Use With Adverse Health Outcomes: A Systematic Umbrella Review.JAMA psychiatry · 2019Pooled it
- Pooled it
- The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis.British journal of clinical pharmacology · 2016Pooled it
- Pharmacovigilance signals for congenital heart disease related to drug exposure: A disproportionality analysis based on the FAERS database.American heart journal plus : cardiology research and practice · 2026Article
- Metabolomic signatures of SSRI exposure during neural differentiation and correlation of lysophosphatidylcholines with early symptoms of neurodevelopmental disorders.EBioMedicine · 2026Article
- Post-marketing safety evaluation of paroxetine: a real-world pharmacovigilance analysis based on the FDA adverse event reporting system.Frontiers in pharmacology · 2026Article
- Prediction of Maternal and Fetal Exposure to Escitalopram, Sertraline, and Paroxetine by Combining Human Ex Vivo Placenta Perfusion Data and Physiologically Based Pharmacokinetic Modeling.Clinical pharmacokinetics · 2025Article
- Drug Repositioning in Doxorubicin-Induced Cardiotoxicity Protection.International journal of molecular sciences · 2025Review
- Selective serotonin reuptake inhibitors induce cardiac toxicity through dysfunction of mitochondria and sarcomeres.Communications biology · 2025Article
- Article
- Drug-Drug Interactions of Selective Serotonin Reuptake Inhibitors: A Pharmacovigilance Study on Real-World Evidence from the EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Consensus Panel Recommendations for the Pharmacological Management of Pregnant Women with Depressive Disorders.International journal of environmental research and public health · 2023Article
- Maternal serotonin: implications for the use of selective serotonin reuptake inhibitors during gestation†.Biology of reproduction · 2023Review
- The Serotonergic System and Bone Metabolism During Pregnancy and Lactation and the Implications of SSRI Use on the Maternal-Offspring Dyad.Journal of mammary gland biology and neoplasia · 2023Review
- Developmental Toxicity Studies: The Path towards Humanized 3D Stem Cell-Based Models.International journal of molecular sciences · 2023Review
- Selective Serotonin Reuptake Inhibitors (SSRIs) in Pregnancy: An Updated Review on Risks to Mother, Fetus, and Child.Current psychiatry reports · 2022Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe aim of this study was to perform an up-to-date meta-analysis on the risk of cardiac malformations associated with gestational exposure to paroxetine, taking into account indication, study design and reference category.
methodA systematic review of studies published between 1966 and November 2015 was conducted using embase and MEDLINE. Studies reporting major malformations with first trimester exposure to paroxetine were included. Potentially relevant articles were assessed and relevant data extracted to calculate risk estimates. Outcomes included any major malformations and major cardiac malformations. Pooled odds ratios and 95% confidence intervals were calculated using random-effects models.
resultsTwenty-three studies were included. Compared with non-exposure to paroxetine, first trimester use of paroxetine was associated with an increased risk of any major congenital malformations combined (pooled OR 1.23, 95% CI 1.10, 1.38; n = 15 studies), major cardiac malformations (pooled OR 1.28, 95% CI 1.11, 1.47; n = 18 studies), specifically bulbus cordis anomalies and anomalies of cardiac septal closure (pooled OR 1.42, 95% CI 1.07, 1.89; n = 8 studies), atrial septal defects (pooled OR 2.38, 95% CI 1.14, 4.97; n = 4 studies) and right ventricular outflow track defect (pooled OR 2.29, 95% CI 1.06, 4.93; n = 4 studies). Although the estimates varied depending on the comparator group, study design and malformation detection period, a trend towards increased risk was observed.
conclusionsParoxetine use during the first trimester of pregnancy is associated with an increased risk of any major congenital malformations and cardiac malformations. The increase in risk is not dependent on the study method or population.
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