“Incidence of Malformations After Early Pregnancy Exposure to Modafinil in Sweden and Norway”, 2020-09-01 (; similar):
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.
…Compared with pregnant women who had not taken modafinil, pregnant women who had taken modafinil were more often overweight or obese and had higher rates of smoking and diagnoses of narcolepsy, multiple sclerosis, and attention-deficit/hyperactivity disorder (Table).
Overall, the rate of major malformations in the unexposed group was 2.1% (n = 40 697). There were 3 modafinil-exposed infants diagnosed as having a major malformation, resulting in a prevalence rate of 2.6% and a crude risk ratio of 1.06 (95% CI, 0.35–3.26). When restricted to only filled prescriptions during the first trimester, 75 pregnancies were exposed and 1 modafinil-exposed infant was diagnosed as having a major malformation (risk ratio, 0.44; 95% CI, 0.06–3.10).
Discussion: In this study, modafinil use during early pregnancy was not statistically-significantly associated with increased risk of major malformations. The combined Norwegian and Swedish study population had a similar proportion of modafinil-exposed pregnancies compared with the Danish study, allowing for more than double the number of exposed infants to be followed up. However, the 95% CIs estimated in this study overlap with those from the Danish study and allow for the possibility of a greater than 3-fold risk as previously reported.4