Escitalopram Induced Congenital, Familial and Genetic Disorders and its Safety in Pregnancy: a Review of Post Marketing Safety Data

Abstract

Background: The aim of this paper is to report escitalopram induced congenital, familial and genetic disorders and its safety in pregnancy, a review of post marketing safety data. The primary focus of the safety monitoring practice iscollection, assessment and reporting of the adverse events(AEs) to medicinal products approved for differentMarketing Authorisation Holders (MAHs).

Materials and Methods: Cumulative data of Individual Case Safety Reports (ICSRs) received from different sourceswithin the time frame of 2014 to 2018 were studied. The ADRs reported to the SOCs (System Organ Class), (a) congenital, familial and genetic disorders and (b) Pregnancy, puerperium and perinatal conditions were focused. The events or case reports which were confirmed by healthcare professional were considered for evaluation. Case listings were retrieved from the safety database and analysed for evaluation.

Results: During this study period 310 escitalopramcases were analysed and 841 events were found. Of these 37 (4.39%) events were reported by HCP, with both the SOCs (a&b). whereas 26 (70.27%) for congenital, familial and genetic disorders and 11 (29.72%) for pregnancy, puerperium and perinatal conditions.

Conclusion: At this point of time by considering congenital, familial and genetic disorders and safety in pregnancy, we measured risk benefit balance of escitalopramis favourable and routine risk minimization measures are sufficient for these risks.