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Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis

Basic Details
Date Posted
Status
In progress
Medical Product
fingolimod
Health Outcome(s)
all congenital malformations
congenital cardiac malformations (primary)
congenital urinary malformations (primary)
Description

This analysis describes clinical characteristics of pregnancies with live birth deliveries among individuals who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no treatment for multiple sclerosis (MS) in the first trimester of pregnancy. In this analysis, we describe the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, or and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ records in the Sentinel Distributed Database (SDD). We did not utilize the Mother-Infant Linkage (MIL) table in this analysis. We distributed this request to 12 Sentinel Data Partners on January 9, 2023. The study period includes data from January 1, 2011 to August 1, 2022.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

A companion analysis describes the clinical characteristics of pregnancies with linked live birth deliveries among individuals with evidence of MS who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no MS treatment in the first trimester of pregnancy. That analysis also describes the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations evaluated based on evidence available in the mothers’ or linked infants’ records in the SDD, from the Sentinel Common Data Model MIL Table. 

Deliverables (1)
Sentinel Analytic Package: Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2011 – August 1, 2022
Analysis Type
Descriptive
Population / Cohort
Females 15 to 50 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Gilenya (Fingolimod) & Congenital Cardiac Malformations, Congenital Urinary Malformations, and all Congenital Malformations
Sentinel Drug Analysis: Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Congenital Cardiac Malformation Algorithm Defined in "Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis"
Congenital Urinary Malformation Algorithm Defined in "Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis"
Congenital Non-Cardiac/Non-Urinary Malformation Algorithm Defined in "Congenital Malformations Observed in the Mother’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis"