The La Arrixaca Environmental Health Unit has centralized the diagnosis of fetal valproate syndrome in Spain
Those affected by fetal valproate syndrome, presumably caused by the antiepileptic Depakine, have won a first court battle in Spain. A court of First Instance in Madrid has sentenced Sanofi to compensate with amounts ranging between 600,000 and 1.3 million euros to the families of three boys who were born with various disabilities after their mothers consumed Depakine during pregnancy. Although the ruling is not final, it is a first precedent that thirty affected people in Spain can take advantage of. All of them have been diagnosed with fetal valproate syndrome at the La Arrixaca Environmental Health Unit, which, led by its manager, Juan Antonio Ortega, has become a reference in this matter.
Depakine is an antiepileptic that for decades was prescribed to pregnant women despite the fact that it increases the risk of neurodevelopmental disorders and malformations in the fetus. The pharmaceutical company defends that the studies carried out for years were not conclusive, and that the scientific community agreed that women of childbearing age should not abandon treatment. But these arguments have not convinced the head of the court of first instance number 91 of Madrid, who is forceful in the sentence, affirming that with the decisions of the company “prescribing doctors and consumers were deprived of the possibility of knowing that sodium valproate caused birth defects in more than 10% of the children of women who took the medication”, as well as “cognitive development problems in 30% to 40% of these children, a risk of autism spectrum disorders three times higher than normal, and five times in the case of childhood autism.
The sentence agrees with three of the four families who went to court in 2019 at the hands of the Murcian lawyer Ignacio Martínez, of the Patient Defender Association, after their children had been diagnosed in La Arrixaca. The judge gives special “evidential importance to the reports issued” by Juan Antonio Ortega, head of the Environmental Health Unit. These reports “highlight the causal relationship of the ailments presented” by the patients “with exposure to sodium valproate” by the mother.
It’s a “pioneer”
The Association of Victims of Valproic Acid Syndrome (Avisav) underlines the “pioneering” character of the sentence. “The teratogenic effects of sodium valproate (Depakine) have been known since 1980, when it was described that intrauterine exposure to valproate caused alterations in the closure of the neutral tube (spina bifida) in children”, emphasizes this organization. “Subsequently, different scientific publications confirmed that it produced malformations”, facial dysmorphia, congenital anomalies, developmental delay, especially in language and communication, and various disorders compatible with an autism spectrum.
For Juan Antonio Ortega, head of the La Arrixaca Environmental Health Unit, what happened with Depakine is similar to what happened with thalidomide, another drug that was prescribed to pregnant women for decades. “It is necessary to improve pharmacovigilance in pregnancy,” he stresses.
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