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Health Canada Health products

ALERTEC (modafinil) and the Risk of Congenital Anomalies

Issued June 20, 2019
Issue
In February 2019, TEVA Canada Innovation informed Health Canada of the results of the 2018 annual report of the ongoing Nuvigil/Provigil (modafinil) Pregnancy Registry in the United States. The results suggested a higher rate of major congenital anomalies, and other adverse reactions, in children exposed to the drug in utero.
Hazard description
Product safety