OBJECTIVES:

This project aims to identify signals of congenital anomaly (CA) related to potentially teratogenic medications use and evaluate these signals based on the available evidence.

METHODS:

Individual case safety reports (ICSRs) of CA were retrieved from the World Health Organization (WHO) global database of individual case safety reports (VigiBase) using specific keywords, in February 2022. Then, the following exclusion criteria were applied; ICSRs with chromosomal anomaly, skeletal dysplasia, or genetic syndrome were excluded since aetiology is assumed not to be teratogenic; ICSRs with only exposed to (folic acid, minerals and/or vitamins); ICSRs with only exposed to topical medications, or non-locally registered drugs. Following, included drug-CA events ICSRs were crosschecked in the local product’s information comparing to U.S. Food and Drug Administration and European Medicines label information, then, identified signals underwent in-depth assessment by conducting a comprehensive safety evaluation using several different evidence sources including literature, global cases retrieved from VigiBase and local cases retrieved from the national pharmacovigilance database of the national pharmacovigilance center at Saudi Food and Drug authority (SFDA) and Periodic Benefit-Risk Evaluation Reports.

RESULTS:

A total of 181 drug-CA pairs were subjected to initial assessment. Of these, 151 drug-CA events were labeled in the Saudi product’s leaflet; 18 drug-CA events were labeled in other stringent regulatory authorities; and 12 drug-CA events were referred to in-depth assessment. The assessment results were one-drug-CA event was probably related, 11 were possibly related, and one was excluded due to off-label use in pregnancy.

CONCLUSIONS:

Post marketing data from VigiBase has successfully improved signal detection of CA related to potentially teratogenic medications use. Further epidemiological studies are needed to quantify the CA risks to help health care professionals to make risk versus benefit decision for using medicines in pregnancy.