Danish study describes a clinically important increased risk of major congenital malformation associated with first trimester modafinil exposure

Lead author of the study and ENTIS member Professor Per Damkier from the Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Denmark, stated that there appears to be about a 3-fold increased risk – while we have a relatively small number of exposed and outcomes (N=49; 6 major malformations), and hence a low precision – the signal is strong and robust to major confounders.

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