On June 20, 2019 Health Canada released a MedEffect Notice advising of an increased risk of spontaneous abortion and major congenital anomalies, including cardiac congenital anomalies in babies born to mothers who use modafinil (brand name ALERTEC) during pregnancy.
Modafinil is a non-amphetamine-based stimulant. In Canada, modafinil is prescribed to prevent the feeling of excessive tiredness symptomatic of narcolepsy, obstructive sleep apnea and shift-work disorder. It has also been prescribed for treatment of the symptoms of attention deficit hyperactivity disorder. It is produced by TEVA Canada Innovation who discovered the increased risk and reported it to Health Canada in February.
Beyond the major health disruptions to pregnant females, modafinil is also shown to reduce the effectiveness of hormonal birth control, thereby increasing the risk of a woman becoming pregnant while on the drug.
It is recommended that females be off modafinil for at least two months before becoming pregnant, and that they obtain a negative result on a pregnancy test in the week before starting the drug.
It was only when animal studies showed developmental toxicity that the U.S. Federal Drug Administration requested a study of women taking the drug in 2018. Results showed congenital anomaly outcomes up to 5x higher than that of the general population. Canadians may be rightfully unsettled to learn that Health Canada received notice of the problem in February this year and waited four months to release the information to the public.
The NHPPA questions the systematic removal of natural health products from the market when the risks associated with pharmaceuticals far outweighs any risk associated with the use of natural remedies. If you are an alternative medicine practitioner, what would you consider supporting women with when facing “excessive tiredness symptomatic of narcolepsy, obstructive sleep apnea and shift-work disorder”.
Help NHPPA continue to fight for your right to treat your body naturally.