Since Monday morning, France has tightened restrictions on the delivery of anti-epileptic drugs such as Dépakine following a decision by theMedicines Safety Agency. These drugs carrying risks for the development of babies caused a scandal in 2015 after the association’s revelations Apesac. If these treatments were already banned for pregnant women, future fathers are now targeted.
Why are these drugs controlled?
According to national health authorities, the valpoate molecule integrated into these anti-epileptic treatments is responsible for malformations and neurodevelopmental disorders in thousands of children. According to Apesac, 8,000 children have been listed with malformations, neurodevelopmental disorders or dys disorders. “But we estimate the number of real victims at 50,000,” recalls 20 MinutesMarine Martin, whistleblower and president of the association helping parents of children suffering from anti-convulsant syndrome.
Why a new reinforcement?
Banned since 2018 for pregnant women, new studies have demonstrated an impact on babies through the father. The European Medicines Agency (EMA) announced in 2023 of a study carried out on the health database numerous patients in several Scandinavian countries and concluding a “moderate” risk of developmental disorders, such as autism, in children of fathers treated with valproate, the molecule also acting on sperm quality. In 2022, in France, 161,392 men were under treatment, according to Apesac. As a reminder, the lifespan of the drug in the body is three months. If you want to become parents, the father or mother must stop this treatment one trimester before conception.
How will these medications be prescribed?
From this Monday, only neurologists, psychiatrists and pediatricians will be able to initiate valproate treatments “for adolescents and men likely to have children”, according to the Medicines Safety Agency. Patients already on treatment will have to change their treatment with a deadline of June 30. A certificate of shared information, particularly on the risks involved, must also be co-signed each year by the patient and the prescriber and presented to the pharmacy, in addition to the prescription, to obtain the medication, writes the ANSM. Dépakine, Micropakine, Dépakote, Dépamide, Divalcote and their generics are targeted. Treatments including carbamazepine (Tegretol and generics) and topiramate (Epitomax and generics) are also subject to the same restrictions.
What do victims’ associations think?
“It’s the result of years of work,” says Marine Martin, even if there is still a long way to go. “We have received many testimonies from men since the Dépakine scandal. We discovered epigenic links via sperm,” explains the president of the Apesac association. But, behind the progress, there are also criticisms. “We deplore the reaction time while the survey on men dates from May 2023. We would also like a system like in the United Kingdom where two neurologists must prescribe these drugs. Finally, men should be able to access samples of (healthy) sperm just in case,” adds the whistleblower. She nevertheless believes that these new constraints will open the way to alternatives in terms of prescription. “In 2022, 23,183 women were still on valproate. And there are 203 pregnancies in 2021 despite the alerts,” displays Marine Martin.
Where is justice?
This new restriction does not come out of nowhere but comes after the particularly decisive judgment in 2024 against Sanofi. After a historic trial, the pharmaceutical group Sanofi was, in fact, declared “responsible for a lack of information on risks” by the Paris judicial court and ordered to pay 300,000 euros to Marine Martin, in the case of Depakine.
A first legal aspect since the president of the association does not intend to stop there. “We hope this year to file the first complaints with the Paris court after the latest revelations,” announced Marine Martin.
Source: www.20minutes.fr
