2024-11-07 05:00:00
A pregnant woman, in Paris, May 12, 2020. JOEL SAGET / AFP
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) which mandated it, “following the request from health professionals and patient associations to improve the readability of pictograms for the public”specifies the DGS. “The information may have been deemed unclear because it could be misinterpreted by pregnant women or those wanting to become pregnant”explains Céline Mounier from the general management of the ANSM.
Remember that since 2017, a pictogram « danger » or ” forbidden “ is affixed to certain boxes of medicines to prevent teratogenic risks (likely to cause malformations in the embryo) or fetotoxic risks (effect on fetal growth and organ development). This information system was set up after the Dépakine (valproate) scandal, a treatment drug epilepsy and bipolar disorders. Known for a long time by Sanofi, its manufacturer, the dangers for 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 neurodevelopmental 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 “Antiepileptics during pregnancy”.
Read the story (2022): Article reserved for our Dépakine subscribers: Sanofi’s responsibility recognized by the courts
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To improve information, the agency set up a temporary scientific committee (CST) at the beginning of 2023 which met around twenty times, held several hearings and concluded, on October 17, a public consultation, including feedback are currently being examined. This instance proposes several changes, including one major one: all medicines would be affected by the new pictograms compared to around 70% today, a third of which include the logo ” forbidden “ and two thirds that of « danger ». Another modification, in addition to the teratogenic and fetotoxic risks, would be specified those of miscarriage 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 women or women of childbearing age to a discussion with health professionals”specifies Céline Mounier. In practice, the risk would go from “unlikely” has “proven” 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.
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**Interview: Understanding Teratogen Warning Symbols on Medications**
**Interviewer**: Good morning, Céline Mounier, thank you for joining us today. As you mentioned, there has been a growing concern regarding the clarity of warning symbols on medicine for pregnant women. Can you elaborate on why this re-evaluation is taking place?
**Céline Mounier**: Good morning! Yes, the re-evaluation of these pictograms is crucial. We received feedback from health professionals and patient associations indicating that the current warnings may not be clearly understood by pregnant women or those planning to become pregnant. The goal is to ensure that the risks associated with certain medications are communicated effectively to prevent any potential harm to the fetus.
**Interviewer**: It’s alarming to hear about the history behind this. Can you explain the background related to the Dépakine scandal and how it has influenced these warnings?
**Céline Mounier**: Certainly. The Dépakine case is a significant example. Although the medication has been on the market since 1967, its teratogenic risks weren’t adequately communicated until much later. This has led to thousands of children suffering from congenital malformations due to their mothers taking the drug during pregnancy. The scandal highlighted the dire need for a more transparent warning system, which is why we introduced the “danger” pictogram in 2017.
**Interviewer**: The introduction of this pictogram was an important step. What measures are being taken now to improve the current warning system?
**Céline Mounier**: We are currently undergoing a public consultation to gather insights on the effectiveness of the symbols. Our aim is to simplify the information so that it is immediately understandable, reducing any chance of misinterpretation. We want women to be fully aware of the risks and make informed decisions.
**Interviewer**: That’s great to hear. With an estimated 100,000 women of childbearing age in France affected by epilepsy and possibly prescribed teratogenic medications, what advice would you give to these women?
**Céline Mounier**: My primary advice is to consult with healthcare providers about any ongoing medications. Communication is key—women should feel empowered to ask questions and discuss potential risks and alternatives with their doctors. The health of both mother and child is of utmost importance.
**Interviewer**: Thank you, Céline, for shedding light on this crucial topic. It’s essential for women to have clear and accessible information regarding medication during pregnancy.
**Céline Mounier**: Thank you for having me. It’s a vital conversation to have, and I hope more women feel encouraged to engage with their healthcare providers.
