Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis

Basic Details
Date Posted
Tuesday, November 17, 2020
Status
Complete
Medical Product
armodafinil
modafinil
Health Outcome(s)
congenital cardiac malformations
Description

In this request we examined characteristics of pregnant women using modafinil or armodafinil, amphetamines, methylphenidate, or who were unexposed to those medical products in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on March 30, 2020. The study period included data from January 1, 2000 to December 31, 2018.

Deliverables (1)
Sentinel Modular Program Report: Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - December 31, 2018
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Females 10 to 54 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis