Teva Canada Innovation notified Health Canada about the results of an on-going study in the United States concerning the congenital effects the sleep drug Alertec (modafinil) might have on unborn children. According to a public announcement published by Health Canada, the study shows that the sleep drugs, Nuvigil and Provigil (modafinil), which are prescribed to treat patients with severe sleep disorders like narcolepsy, severe sleep apnea, and shift work disorders, may cause congenital “abnormalities” and might cause additional health problems if the child was exposed to the drug while growing in the uterus. Physicians prescribe Alertec to help patients suffering from similar severe sleep problems. As a result of these findings, Health Canada concluded that women who are pregnant or might become pregnant should not take Alertec because of the threat the drug presents to the unborn baby.
Health Canada advises physicians to discuss the possible side effects at great length with their female patients of reproductive age. The doctors must address the potential congenital birth defects linked to taking Alertec, Nuvigil, or Provigil if the patient was to become pregnant while taking the drug. The physician must also discuss the requirement that women taking Alertec must have a negative pregnancy test at least one week before starting the drug, take effective contraception while on the drug and for two months after stopping the therapy. Notably, doctors must inform their patients that steroid-based contraception loses its effectiveness while taken contemporaneously with Alertec. Additionally, Health Canada suggests that women should avail themselves to other forms other contraception while taking Alertec in addition to the steroid-based contraceptives.
Health Canada stated it would work with Teva Canada Innovation to develop appropriate warning labels for the medication. Furthermore, Health Canada indicated that it would work closely with generic modafinil manufacturers to create adequate warnings as well.
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