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Congenital Malformations Observed in the Mother’s or Linked Infant’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 the clinical characteristics of pregnancies with linked live birth deliveries among individuals with evidence of multiple sclerosis (MS) who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no MS treatment in the first trimester of pregnancy. This analysis also describes the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ or linked infants’ records in the Sentinel Distributed Database (SDD), from the Sentinel Common Data Model Mother-Infant Linkage (MIL) Table. We distributed this request to five Sentinel Data Partners on January 24, 2023. The study period includes data from January 1, 2011 to June 30, 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 clinical characteristics of pregnancies with 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. In that analysis, we describe the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ records in the SDD. We did not utilize the MIL table in that analysis.

Deliverables (2)
Sentinel Analytic Package: Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis Sentinel Modular Program Report: Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2011 – June 30, 2022
Analysis Type
Descriptive
Population / Cohort
Females 10 to 54 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 Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis
Congenital Cardiac Malformation Algorithm Defined in “Congenital Malformations Observed in the Mother’s or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis”
Congenital Urinary Malformation Algorithm Defined in “Congenital Malformations Observed in the Mother’s or Linked Infant’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 or Linked Infant’s Records Following Fingolimod Use During Pregnancy: A Descriptive Analysis”