Modafinil, sold under the brand Alertec, is used to help treat adult patients with sleeping disorders, such as narcolepsy, obstructive sleep apnea and shift work disorder. Alertec is sold in Canada in 100 mg tablets.
The FDA has labelled it a “wakefulness-promoting drug,” that essentially helps patients with “excessive sleepiness.”
However, Health Canada said Thursday that it has been associated with “major fetal congenital malformations,” including ones related to the heart. There have also been reports that it has led to low fetal growth, and poor physical development of babies.
Health care professionals are now being advised to ask patients with reproductive potential to take a pregnancy test within one week of starting the medication, and to use contraceptives once on the treatment.
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“Patients using steroidal contraceptives should use alternative or additional methods of contraception during the ALERTEC treatment, and for two months after stopping ALERTEC treatment,” a release explains, noting that the medication could reduce the effectiveness of some birth control.
Steroidal contraceptives include methods such as birth control pills, injections, implants, intrauterine devices or patches.
Health Canada said it is working with the manufacturer of the drug, Teva Canada Innovation, to update product information with these new findings.
The findings came in a 2018 report from the United States, which suggested that the drug causes anomalies and other “adverse reactions” among children who are exposed before birth. Health Canada was informed of the findings by Teva in February 2019.
Health Canada added in its release that patients using Alertec should be mindful of potential adverse effects, and consult a healthcare professional if needed.
In its guide to Alertec use, Teva explains patients may experience side effects such as rashes, swelling that leads to difficulty breathing and fatigue, among others.