The narcolepsy medicine modafinil doesn't appear to increase the risk of birth defects, according to a new study that contradicts earlier research.
"This study is based on twice as many pregnancies as earlier studies, and we find no increase in the risk of malformation in infants exposed to modafinil during pregnancy," lead author Carolyn Cesta, of the Karolinska Institute in Sweden, said in an institute news release. She's a researcher at the Center for Pharmacoepidemiology.
The drug is used to improve wakefulness in adults with narcolepsy, multiple sclerosis-related fatigue and, in some cases, attention deficit hyperactivity disorder. However, previous research has linked modafinil with an increased risk of birth defects in babies born to mothers who took the medication while pregnant.
To investigate that possible connection, researchers analyzed data from almost 2 million pregnancies in Sweden and Norway between 2005 and 2017.
They compared women who took modafinil from 30 days before conception to the end of their first trimester with women who didn't take the drug.
Of the 133 infants whose mothers took modafinil during pregnancy, 2.6% were born with a major birth defect, compared with 2.1% of infants whose mothers didn't take the drug. Researchers said the difference is not statistically significant.
The study was published Sept. 1 in the Journal of the American Medical Association.
"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," said study co-author Kari Furu, a senior researcher at the Norwegian Institute of Public Health.
The U.S. National Library of Medicine has more on modafinil.