In their Research Letter, Kaplan and colleagues1 report the teratogenicity of modafinil and/or armodafinil used within 6 weeks of becoming pregnant and during pregnancy based on data from the US Provigil/Nuvigil Pregnancy Registry. Of 102 prospective live births, 13% (n = 13) had major congenital malformations, a prevalence higher than the approximately 3% in the general population. Among these newborns with malformations, 4 were diagnosed with congenital torticollis, 2 with hypospadias, and 3 with congenital heart defects, yielding a cardiac malformation prevalence of 3% compared with about 1% in the general population.2
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Ghaffari N, Robertson PA. Caution in Prescribing Modafinil and Armodafinil to Individuals Who Could Become Pregnant. JAMA Intern Med. 2021;181(2):277–278. doi:10.1001/jamainternmed.2020.4206
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