Currently, the National Agency for the Safety of Medicines and Health Products (ANSM) is reevaluating the pictograms on medicine packaging that warn of the dangers for pregnant women. It was the General Directorate of Health (DGS) that commissioned it, “following the request of health professionals and patient associations to improve the readability of the pictograms for the public”specifies the DGS. “The information may have been considered unclear because it could be misinterpreted by women who are pregnant or want to become pregnant.”explains Céline Mounier from the general directorate of the ANSM.
Remember that since 2017, a pictogram ” danger “ EITHER ” forbidden “ It is placed in certain boxes of medicines to prevent teratogenic risks (which can cause malformations in the embryo) or fetotoxic risks (effect on fetal growth and organ development). This information system was created after the Dépakine (valproate) scandal, a treatment drug epilepsy and bipolar disorders. Long known to Sanofi, its manufacturer, the dangers to the fetus were slow to be reported in the instructions.
In France, where it has been marketed since 1967, Dépakine has proven to be responsible for congenital malformations and neurological development disorders in thousands of children of mothers treated during pregnancy. Likewise, other antiepileptic treatments present risks. Around 100,000 women of childbearing age are affected by the disease, according to the 2023 ANSM report “Antideleptics during pregnancy.”
To improve information, the agency created a temporary scientific committee (CST) in early 2023 that met twenty times, held several hearings and concluded, on October 17, a public consultation, whose comments are currently under review. This instance proposes several changes, including an important one: All medicines would be affected by the new pictograms, compared to the current 70%, of which a third includes the logo. ” forbidden “ and two thirds of ” danger “. Another modification, in addition to the teratogenic and fetotoxic risks, would be those of abortion and neurodevelopmental disorders.
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This new device “would not specify the nature of the risk, but would give a scale of risk, with a course of action that systematically refers pregnant or childbearing women to a discussion with health professionals”specifies Céline Mounier. In practice, the risk would go from “unlikely” has “tried” with four associated color codes (blue, orange, red, purple). To assess this risk, the CST proposes to rely on the summary of product characteristics (SmPC) of each medicine.
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