Modafinil is used to improve wakefulness in adults with excessive sleepiness due to narcolepsy, for fatigue related to multiple sclerosis, and for the treatment of attention-deficit/hyperactivity disorder. In 2018, an interim report from a manufacturer-established pregnancy registry reported a prevalence of 15% for major malformation in infants exposed to modafinil during pregnancy, spurring regulatory bodies to amend product information.1-3 Recently, a Danish study reported a major malformation rate of 12% (n = 6) among 49 infants exposed to modafinil during early pregnancy compared with 3.9% (n = 32 466) among 828 644 unexposed to modafinil (adjusted odd ratio, 2.7; 95% CI, 1.1-6.9).4 To add to the emerging evidence, we investigated if modafinil use during early pregnancy was associated with major malformations in Norway and Sweden.
Cesta CE, Engeland A, Karlsson P, Kieler H, Reutfors J, Furu K. Incidence of Malformations After Early Pregnancy Exposure to Modafinil in Sweden and Norway. JAMA. 2020;324(9):895–897. doi:10.1001/jama.2020.9840
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