Modafinil and Armodafinil in Pregnancy: Is There an Increased Risk for Congenital Malformations?
BACKGROUND AND PURPOSE:
The effects of modafinil and armodafinil use during pregnancy are unknown
These drugs are used to improve wakefulness in the treatment of narcolepsy, obstructive sleep apnea, or shift work disorder
Reproductive toxic effects have been demonstrated in animal models
Kaplan et al. (JAMA Internal Medicine, 2020) report on data from the US Provigil/Nuvigil Pregnancy Registry, a postmarketing database
Used to collect and evaluate pregnancy and fetal outcomes in individuals who could have been exposed to modafinil or armodafinil
Ongoing prospective cohort study
Any individual exposed to modafinil and/or armodafinil within 6 weeks prior to conception or during pregnancy
Enrollment in the US Provigil/Nuvigil Pregnancy Registry is voluntary
A pregnancy was classified as prospective if enrollment occurred before knowledge of the pregnancy outcome or detection of a congenital malformation at a prenatal test
A pregnancy was classified as retrospective if enrollment occurred after knowledge of the pregnancy outcome or congenital malformation at a prenatal test
Major congenital malformations (MCMs)
Spontaneous abortion (<20 weeks’ gestation)
Elective pregnancy termination
Fetal death (≥20 weeks gestation).
148 individuals were enrolled through 2019
Modafinil: 81 individuals
Armodafinil: 66 individuals
Both: 1 individual
Narcolepsy was the main indication reported for use (70%)
Prospective pregnancy outcomes
102 prospective live births
13% had MCMs (prevalence in general population in ~3%)
Congenital torticollis: 4
Congenital heart defects: 3
Pooling the data for both prospective and retrospective live births resulted in the same MCM prevalence of 13%
Exposure to modafinil or armodafinil in utero may increase the risk of major congenital malformations
Causality remains unknown and limitations include
Selection bias owing to voluntary enrollment | Incorrect or incomplete data reporting | No internal comparison group | Small sample size
However, authors suggest that
…the potential increased risk of MCMs provides an impetus for health care professionals to enhance the benefit-risk monitoring of modafinil and/or armodafinil use in pregnant individuals and individuals who may become pregnant
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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