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Use of Multiple Sclerosis Drugs Among Pregnant Women with Live-Birth Deliveries: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
alemtuzumab
cladribine
dalfampridine
dimethyl fumarate
diroximel fumarate
fingolimod
glatiramer acetate
interferon beta-1A
interferon beta-1B
mitoxantrone
natalizumab
ocrelizumab
peginterferon beta-1a
siponimod
teriflunomide
Description

In this report we describe exposure to multiple sclerosis (MS) drugs before, during and after pregnancies resulting in a live-born delivery among women in the Sentinel Distributed Database (SDD). We also describe MS drug use among matched women during episodes without evidence of a live-birth delivery.

The study period includes data from January 1, 2001 to December 31, 2020. We distributed this request to six Sentinel Data Partners on June 25, 2021.

Deliverables (1)
Sentinel Modular Program Report: Use of Multiple Sclerosis Drugs Among Pregnant Women with Live-Birth Deliveries: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2001- December 31, 2020
Analysis Type
Descriptive
Population / Cohort
Females 10 to 49 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Multiple Sclerosis (MS) Drugs & Exposure before, during, and after Pregnancy
Describing Prenatal Exposures and Evaluating Maternal and Infant Outcomes in Sentinel