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Provigil (Modafinil) and Nuvigil (Armodafinil) & Congenital Cardiac and Non-Cardiac Malformations

Basic Details
Status
Complete
Last Updated
Tuesday, October 15, 2024
Original Posting Date
Health Outcome(s)
cardiac congenital malformations
non-cardiac congenital malformations
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The FDA initiated this Sentinel study to determine if modafinil/armodafinil exposure in utero was associated with an increased risk of major congenital malformations. Some, but not all previous studies have reported an association between in utero exposure to modafinil/armodafinil and increased risk of major congenital malformations. Data from the Nuvigil (armodafinil)/Provigil (modafinil) pregnancy registry suggested potential safety signals of cardiac defects, overall congenital malformations, and musculoskeletal defects. 

This study found that modafinil/armodafinil exposure in utero was not associated with cardiac malformations. Additionally, there was no association between modafinil/armodafinil exposure in utero and the risk of non-cardiac, musculoskeletal, or urinary malformations.

These findings have informed an ongoing discussion about updating the Risk Summary and Data (Human Data) sections of the Prescribing Information for both Provigil and Nuvigil labeling.

Analytic Code Link(s) (2)
Risk of Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis Risk of Non-Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis
Result(s) (3)
Risk of Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis Risk of Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis Risk of Non-Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (1)
Presentation: Assessment of Non-Cardiac Congenital Malformations and in Utero Exposure to Modafinil/Armodafinil in the Sentinel Distributed Database