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,
Health Canada said 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:
- Women who are pregnant, or plan to become pregnant, must not use Alertec.
- Hormonal birth control methods, such as birth control pills, injections, implants, intrauterine devices or patches, may not work as well when used at the same time as Alertec. Women who use these types of birth control may have a higher chance of getting pregnant while taking Alertec, and for two months after stopping it. Patients should talk to a health-care professional about birth control methods that are right for them.
- Women should take a pregnancy test within a week before starting treatment with Alertec and ensure they are not pregnant.
