Wakefulness drug modafinil tied to fetal harm, Health Canada warns
Women who are pregnant or may become pregnant should avoid the wakefulness-promoting drug modafinil, sold as Alertec, to prevent serious harm to the fetus, Health Canada warns.
In a notice to health-care professionals on Thursday, Alertec has been associated with "cases of major fetal congenital malformations, including congenital cardiac anomalies."
The drug is sold in 100 mg tablets, including generic tablets, to treat adults with excessive sleepiness.
Modafinil is prescribed to treat sleepiness from conditions such as narcolepsy (which can manifest with sudden attacks of sleep that cannot be controlled), obstructive sleep apnea and shift work disorder.
Health Canada said findings from international reports showed Alertec may cause harm to an unborn baby. The regulator added:
The drug is a stimulant that is also used to treat attention deficit hyperactivity disorder.