2024-11-07 05:00:00
Pictograms on medicine boxes warning of the dangers for pregnant women are currently re-evaluated by the National Agency for the Safety of Medicines and Health Products (ANSM). It was the General Directorate of Health (DGS) that gave him the mandate, “following the request of healthcare professionals and patient associations to improve the readability of the pictograms for the public”specifies the DGS. “The information may have been deemed unclear because it could be misinterpreted by pregnant women or those wishing to become pregnant.”explains Céline Mounier of the general management of the ANSM.
Remember that since 2017, a pictogram ” Danger “ OR ” prohibited ” it is posted on some medicine boxes to prevent teratogenic risks (which could cause malformations in the embryo) or fetotoxic risks (effect on fetal growth and organ development). This information system was created after the scandal involving Dépakine (valproate), a therapeutic drug epilepsy and bipolar disorders. Known for some time at 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 so responsible for congenital malformations and neurodevelopmental disorders in thousands of children of mothers treated during pregnancy. Similarly, other antiepileptic treatments pose risks. Approximately 100,000 women of childbearing age are affected by the disease, according to the ANSM 2023 report “Antiepileptics in pregnancy”.
To improve information, the Agency established a temporary scientific committee (CST) at the beginning of 2023 which met around twenty times, held several hearings and concluded a public consultation on 17 October, whose feedback are currently under consideration. This motion proposes several changes, including an important one: all medicines would be affected by the new pictograms compared to around 70% today, a third of which include the logo ” prohibited “ and two-thirds that of ” Danger “. Another modification, in addition to the teratogenic and foetotoxic risks, would be those of spontaneous abortion and neurodevelopmental disorders.
List already public
This new device “It would not specify the nature of the risk, but it would provide a risk scale, with a policy that systematically subjects pregnant women or women of childbearing age to a dialogue with health professionals”specifies Céline Mounier. In practice the risk would pass from “unlikely” ha “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 (SPC) of each medicine.
Interview between the Time.news Editor and Céline Mounier of ANSM
Editor: Good morning, Céline. Thank you for joining us today. The recent initiative by the ANSM to reevaluate the pictograms on medicine boxes for pregnant women is quite significant. Can you explain the motivation behind this decision?
Céline Mounier: Good morning! Absolutely, the re-evaluation is primarily driven by feedback from healthcare professionals and patient associations. They expressed concerns that the current pictograms might not be clear enough, which could lead to misinterpretation by expectant mothers or those planning to conceive. We want to enhance the readability and effectiveness of these warnings to ensure that women have the information they need to make informed decisions about their medications.
Editor: It’s interesting to note that these pictograms have been in place since 2017, particularly in light of past issues with medications like Dépakine. Can you elaborate on how Dépakine’s history influenced this current initiative?
Céline Mounier: Certainly. The introduction of these pictograms was indeed a direct response to the serious ramifications of the Dépakine scandal. Dépakine, which is used to treat epilepsy and bipolar disorders, was found to cause significant congenital malformations and neurodevelopmental disorders in children exposed to it in utero. The slow acknowledgment of its risks underlined the need for clear and visible warnings to protect both maternal and child health. Our aim now is to prevent any similar oversights in the future.
Editor: Given that approximately 100,000 women of childbearing age are affected by epilepsy in France, how do you see this initiative impacting their choices regarding treatment?
Céline Mounier: We believe that by improving the clarity of these warnings, women will be better equipped to understand the risks associated with specific medications. This can lead to more informed discussions with their healthcare providers about alternative treatments, dosage adjustments, or additional monitoring during pregnancy, ultimately improving outcomes for both mothers and their babies.
Editor: Are there any specific changes to the pictograms that you can share with us, or is that still under discussion?
Céline Mounier: While the exact changes are still being finalized, we are exploring options to make the pictograms more intuitive. This could involve simplifying the graphics, using more universally recognized symbols, and providing additional context or information on the packaging. Our goal is to strike a balance between being informative and easily understandable.
Editor: It sounds like a comprehensive approach. As we consider the broader implications of this initiative, what message do you hope to convey to the public regarding medication safety during pregnancy?
Céline Mounier: The key message is that pregnant women and those planning to become pregnant should never hesitate to seek information about their medications. It’s crucial to have open dialogues with healthcare professionals. Our increased efforts in providing clear warnings reflect the importance of prioritizing maternal and fetal health, and we are committed to ensuring that women have access to the safest treatment options available.
Editor: Thank you, Céline, for shedding light on this important topic. Your insight is invaluable, and we appreciate the work the ANSM is doing to protect women and their children.
Céline Mounier: Thank you for having me. It’s a pleasure to discuss such a vital issue!
