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First-trimester pregnancy exposure to modafinil and risk of congenital malformations

JAMA Feb 02, 2020

Damkier P, et al. - Modafinil is used as a stimulant drug for the treatment of excessive daytime sleepiness correlated with narcolepsy. Sometimes, it is also utilized off-label for fatigue in multiple sclerosis in Denmark. During pregnancy, Modafinil has been discouraged because of a lack of safety data. The manufacturer alerted healthcare professionals that an interim analysis of postmarketing surveillance data identified major malformations among 15% of children exposed to modafinil during pregnancy in comparison with 3% in the background population in June 2019.
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