Medications against acne based on isotretinoin taken during pregnancy lead, in addition to possible malformations, to the risk of neurodevelopmental disorders, of the autistic type, in the child.
- Isotretinoin-based medicines are associated with a risk of more than 30% of the occurrence of malformations, such as abnormalities of the brain, face or heart, in children exposed in utero.
- The Agency insists above all on the neuro-developmental risks which are not listed on the leaflets of these drugs.
- The ANSM will study the feasibility of a study to better understand these risks.
Despite measures of good use, isotretinoin-based acne treatments continue to be used by many pregnant women, exposing children to the risk of malformations. In a press release published on February 18, the National Medicines Safety Agency (ANSM) also warns of the risk of neurodevelopmental disorders, such as autism, in children. “This risk is under investigation”, she adds.
A new risk for the fetus
Taking these drugs – Contracne, Curacne, Procuta or the generic Isotretinoin Acnetrait – “is associated with a risk of more than 30% of occurrence of malformations, such as abnormalities of the brain, face or heart, in children exposed in utero”, advances the ANSM. The Agency insists above all on the neuro-developmental risks which are not listed on the notices of these drugs which are content to mention the risks of fetal malformations without specifying the risks of appearance of these disorders which are nevertheless associated with them. “The absence of abnormalities visible on ultrasound during pregnancy or at birth does not make it possible to anticipate that the child will not present with disorders, in particular neurodevelopmental disorders such as mental retardation or functional delay. motor skills (balance, walking, etc.)”, she adds.
The ANSM warns of this new risk for the future baby “following the declaration to the national network of pharmacovigilance centers of a suspicion of autistic disorders in a young child exposed during pregnancy to isotretinoin and born without visible malformation”, she reveals. These elements led the Agency to consider the existence of a “potential risk”. To confirm this risk, the Epi-flagship structure “will study the feasibility of a pharmacoepidemiology study on health insurance data.” ANSM will also share data on the risk of neurodevelopmental disorders with the European Medicines Agency (EMA).
Be careful when taking these drugs
Finally, the Agency recalls that medicines based on oral isotretinoin “should under no circumstances be taken during pregnancy or in women of childbearing age, unless measures to prevent pregnancy are in place: highly effective and uninterrupted contraception and the performance of pregnancy tests before, monthly during the whole treatment then one month after stopping the treatment.” In 2019, around 125,000 people were being treated with these drugs.
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