A literature review: effects of Clonazepam use in pregnancy on the risk of birth malformations

Abstract

Psychotropic drugs such as benzodiazepines are often prescribed to treat anxiety, depression, or seizure disorders, as pregnancy presents distinct physiological and psychological challenges. Clonazepam is one such medication frequently prescribed for its anticonvulsant and anxiolytic properties; however, its safety during pregnancy remains uncertain due to concerns about placental transfer and fetal exposure. Through a systematic literature review, this study aims to evaluate the relationship between Clonazepam use during pregnancy and the risk of congenital malformations. A detailed literature search was conducted using databases including PubMed, ScienceDirect, Scopus, ResearchGate, Google Scholar, and Medline, focusing on studies published between 2000 and 2025. Both clinical and observational studies involving pregnant women exposed to Clonazepam or similar benzodiazepines were included for consideration. Records of dosage, exposure duration, maternal characteristics, and fetal outcomes were extracted and assessed for quality in accordance with PRISMA and Newcastle–Ottawa Scale guidelines. The results showed that using clonazepam alone while pregnant is not strongly linked to major birth defects, which means there is a low risk of teratogenesis. However, sporadic instances of microcephaly and minor neurodevelopmental consequences in polytherapy exposures underscore the necessity for prudent therapeutic application. Although, the overall teratogenic risk remains inconclusive, the available evidence suggests a possible association between Clonazepam exposure and increased risks of low birth weight, preterm birth, and mild congenital anomalies. The study emphasizes the need for cautious clinical use and further large-scale research to clarify the safety of Clonazepam during pregnancy.