CANADA – According to an online report at healthycanadians.gc.ca, ALERTEC (modafinil) is for the treatment of excessive tiredness in adults who suffer from narcolepsy, shift work disorder and obstructive sleep apnea. After toxicity was observed during studies using animals, the United States Food and Drug Administration requested that studies be conducted regarding pregnancy and fetal outcomes that are associated with the drug.
Back in February of 2019, TEVA Canada innovation informed Health Canada of the results of a 2018 annual report of the Nuvigil/Provigil Pregnancy Registry. This report indicated that there were cases of spontaneous abortion and major congenital abnormalities, including cardiac congenital abnormalities. The frequency of the major congenital anomalies is 17.3% and cardiac anomalies is 4% that are associated with exposure to ALERTEC. This is greater than the general population which came out to 3% and 1% respectively. There have also been post marketing reports of malformations and low fetal growth, as well as cases of infants who did not thrive, meaning, poor physical development.
Based upon the findings from the Pregnancy Registry and from post-marketing cases reporting major congenital anomalies, the CPM was subject to an update to include a contraindication of the use of ALERTEC during pregnancy and to provide additional details on the findings of the registry.
ALERTEC is indicated for the treatment of people that suffer from excessive sleepiness due to the following medical issues:
- People who suffer from this condition experience sudden sleep attacks that are uncontrollable.
- Obstructive sleep apnea. Individuals who suffer from this condition experience breathing issues while sleeping.
- Shift work disorder. People with this condition have strong feelings of sleepiness when they work during normal periods of sleep.
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