the modafinil, psychostimulant prescribed for the treatment of narcolepsy, increases the risk of birth defects in children exposed during pregnancy, based on an assessment by the European Medicines Agency. A danger now written on the instructions. In a July 4 press release, the French National Agency for Medicines and Health Products Safety (ANSM) therefore recommends that caregivers no longer prescribe it to pregnant women.
Narcolepsy, also called Gélineau disease, is a sleep disorderchronic which causes severe drowsiness during the day, with drowsiness against which the patient is sometimes unable to fight. He can suddenly fall asleep anytime and anywhere, at work, in the car, while he is talking … Involved? A loss of neurons that synthesize a protein, hypocretin. In France, one in 2,800 people is affected by the pathology, according to the encyclopedia Orphanet.
Focus on alternatives and strengthen contraception
The function of modafinil is thus to improve patient alertness. But not without risk for the baby, reveals the American registry monitoring pregnancies exposed to this drug. The ANSM therefore invites doctors to “favor non-drug alternatives (behavioral approaches, sleep hygiene and scheduled naps during the day)”.
The harms of the product would not stop there. In view of the dangers involved, women of childbearing age treated with this psychostimulant should use a effective contraception. But it turns out that the treatment decreases the effectiveness of the latter, pills all strengths, patches and implants, including hormonal intrauterine device. “Other contraceptive methods or associated methods are recommended in treated patients”, indicates the drug gendarme.
Finally, the ANSM invites women with narcolepsy “to contact their specialist doctor, their attending physician or their pharmacist if they have any questions about their treatment”whether pregnant or of childbearing age.
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