Neurological drugs induced congenital anomalies: A pharmacovigilance analysis of neonatal reports in the FDA adverse event reporting system (FAERS).

BACKGROUND

Neurological drugs may have potential associations with embryogenesis, neurological development, growth and subsequent paediatric progress. However, further study is required to update and refine our understanding.

OBJECTIVE

The aim of this paper is to study the incidence of commonly used neurologic drugs such as antidepressants, antiepileptics and antipsychotics in newborns with congenital anomalies using the FAERS database.

METHODS

Spontaneously reported cases involving congenital anomalies in newborns (under 28 days old) were extracted from the FAERS database covering January 2004 to June 2023. We employed four disproportionality analysis methods (ROR, PRR, BCPNN, MGPS) to identify signals associated with congenital anomalies for each drug.

RESULTS

The FAERS database comprises 6208 cases reporting congenital anomalies. After conducting confirmatory analysis, it was found that there were 6014 reports linked to the primary suspect drug, involving a total of 195 drugs. Using the four signal detection methods, neurological drugs exhibited the highest number of safety signals associated with congenital anomalies. Further categorization revealed that Antidepressants represented the highest number of drugs, with Psychotropics and Antiepileptics equally ranking second. These drugs showed a higher frequency of signals in the heart organs, nervous system, respiratory system, and musculoskeletal tissues.

CONCLUSIONS

Analysis of the FAERS database revealed potential associations between neurological drugs and congenital anomalies. Specifically, safety signals for antidepressants, antiepileptics, and antipsychotics were disproportionately reported for anomalies affecting the cardiovascular, nervous, and respiratory systems. These findings provide insights for the cautious use of these medications during pregnancy and highlight areas for further clinical and epidemiological investigation.