This acne medication can only be prescribed by dermatologists.
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Alexandre GELEBART / 20MINUTES
The National Agency for the Safety of Medicines and Health Products (ANSM) announced that oral isotretinoin, an acne treatment, taken during pregnancy presented a "potential risk" of seeing neurodevelopmental disorders such as autistic in unborn children.
It also has a risk of more than 30% of developing malformations in fetuses in the brain, heart or face.
The health agency recalls that these oral isotretinoin-based drugs, prescribed by dermatologists, should not be used during pregnancy or in women of childbearing age who are not under contraception.
A future study on health insurance data?
She recommends that women stop treatment if a pregnancy occurs and see a doctor.
The ANSM noted that the ultrasound could not reveal a "visible abnormality" but that "neuro-developmental disorders such as mental retardation or delay in motor functions" could nevertheless occur.
This Thursday, the agency said that investigations were underway.
To confirm this risk, the Epi-flagship structure will determine whether a study on health insurance data is feasible.
Note that in 2019, approximately 125,000 people were treated with these oral medications.
This “potential risk” came to light after a suspicion of autistic disorders in a young child exposed during pregnancy to isotretinoin and born without visible malformation.
It was the national network of pharmacovigilance centers that received the report.
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