HealthDay News – Modafinil use during early pregnancy is not associated with significantly increased risk for major malformations in exposed infants, according to a research letter published online September 1 in the Journal of the American Medical Association.

Carolyn E. Cesta, PhD, from the Karolinska Institutet in Stockholm, and colleagues identified all singleton pregnancies resulting in live births in nationwide medical birth registers in Norway and Sweden to examine the association between modafinil use in early pregnancy and major malformations in exposed infants.

Overall, 133 of the 1,917,605 pregnancies were exposed to modafinil during early pregnancy. The researchers found that 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. In the unexposed group, the rate of major malformations was 2.1%. Three modafinil-exposed infants were diagnosed with a major malformation, for a prevalence rate of 2.6% and a crude risk ratio of 1.06 (95% confidence interval, 0.35 to 3.26). On restriction to filled prescriptions during the first trimester, 75 pregnancies were exposed and 1 major malformation was identified in a modafinil-exposed infant (risk ratio, 0.44; 95% confidence interval, 0.06 to 3.10).

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“These results illustrate the need to focus on performing large and sufficiently powered studies for drug safety in pregnancy research, preferably from several countries, when exposures and outcomes are rare,” the authors write.

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