Narcolepsy drug did not increase risk of fetal malformation

To discover more about the potential risks of modafinil use during pregnancy, researchers at Karolinska Institutet in Sweden and the Norwegian Institute of Public Health have now conducted a much larger study using data from each country’s health registries.

Two million women in Sweden and Norway

The study is based on almost two million pregnancies between 2005 and 2017 in Sweden and Norway, and compared women who took modafinil from 30 days before conception to the end of the first trimester with women who did not take the drug at all.

A total of 133 (0.007 per cent) of the infants had had in-utero exposure to modafinil, and of them three (2.6 per cent) were born with a major malformation, as compared with 2.1 per cent of the non-exposed infants. This represents a relative risk of 1.06, a difference that is not statistically significant.

The researchers therefore draw the conclusion that there is no increase in the risk of malformation for infants exposed to modafinil during early pregnancy compared with non-exposed infants.

“Our results show how important it is to combine data sources, ideally from several countries, when examining the impact on a fetus of a drug that relatively few people use,” says Kari Furu, senior researcher at the Norwegian Institute of Public Health and the study’s last author.

Source: Karolinska Institutet

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