Claudia-Marina Ichim 1, 2, Adelina Dobrin 1 *, Silvana-Adriana Basa 1, Cosmin Mihalache 3, Manuela Mihalache 3, Gabriela Cioca 3, 4
1 Residency Department, Faculty of Medicine, Lucian Blaga University of Sibiu, Sibiu, Romania
2 Neurosience Research Centre, Dr Gh. Preda Psychiatric Hospital of Sibiu, Sibiu, Romania
3 Preclinical Department, Faculty of Medicine, Lucian Blaga University of Sibiu, Sibiu, Romania
4 Neuroscience Research Centre, Lucian Blaga University of Sibiu, Sibiu, Romania
* Correspondence to: Adelina Dobrin, Residency Department, Faculty of Medicine, Lucian Blaga University of Sibiu, 2A Lucian Blaga Street, Sibiu, 550169, Romania. E-mail: adeldobrin@gmail.com
Abstract
Mental disorders represent a significant global health challenge and encompass a broad spectrum of conditions that are often difficult to manage. A notable proportion of pregnant women experience psychiatric disorders, which raises complex considerations regarding the balance between therapeutic benefits for the mother and potential risks to fetal development. Olanzapine and quetiapine, two second-generation antipsychotics, are commonly prescribed during pregnancy in such cases. Using the European Medicines Agency pharmacovigilance database, 375 individual case safety reports (ICSRs) associated with olanzapine and quetiapine and related to newborns (0–1 month) from 2013 to 2023 were identified, and descriptive analysis was performed. The analysis identified 119 ICSRs associated with olanzapine and 256 ICSRs associated with quetiapine. A total of 396 adverse events were reported for olanzapine and 1,016 for quetiapine. The most commonly reported events for olanzapine and quetiapine were fetal exposure during pregnancy and neonatal drug withdrawal syndrome. The primary indications for olanzapine included “Schizophrenia spectrum and other psychotic disorders” and for quetiapine “Bipolar and related disorders”, followed by “Schizophrenia spectrum and other psychotic disorders”. Additionally, a total of 49 distinct medicinal products were reported in combination with olanzapine, and 43 with quetiapine. Although olanzapine and quetiapine are commonly used in pregnant women without significant issues, reports of adverse reactions remain essential. Data from pharmacovigilance databases play a key role in collecting and analyzing these reports, helping clinicians evaluate safety, identify potential risks, and make informed decisions to protect both maternal health and fetal development.