On March 17, the insurer of the pharmaceutical company Sanofi was sentenced by the court of first instance number 91 of Madrid, to compensate three families with an amount between 600,000 and 1.3 million euros in relation to the commercialization of the antiepileptic Depakine given the secondary effects observed in pregnant women.

Teratogenic effects have been detected such as congenital malformations compatible with the phenotype of fetal syndrome due to valproate, the active ingredient of Depakine, characterized by facial dysmorphia, congenital anomalies, developmental delay, language and communication, and autism-related disorders.

The sentence states that “Sanofi’s behavior deprived prescribing doctors and consumers of the possibility of knowing that sodium valproate caused congenital malformations in more than 10% of children […], cognitive development problems in 30 -40% of these children and a risk of suffering autism spectrum disorders between three and five times higher than normal.

The cases of minors have been diagnosed by the Pediatric Environmental Health Unit of the Virgen de la Arrixaca Hospital, led by Dr. Juan Antonio Ortega, where at least 25 cases have been diagnosed. The first lawsuit took place in April 2019, by 4 families who denounced the pharmacist accusing it of “information deficit” regarding the consequences of the administration of this drug. The recent ruling of March compensates 3 of the 4 plaintiff families, considering the last one as a prescribed case (see more).

The Association of Victims of Valproic Acid Syndrome assures that “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 neural tube (spina bifida) in children”.

This case has similarities with the one known as the Thalidomide catastrophe, a drug that was withdrawn after producing teratogenic effects and other agenesis in many children. This case prompted the creation of the Declaration of Helsinki (1964) to establish ethical principles on medical research involving human beings. Antonio Ortega states “it is necessary to improve pharmacovigilance in pregnancy”.

The pharmaceutical company alleges that “studies carried out over the years were inconclusive, and that the scientific community agreed that women of childbearing age should not abandon treatment.”

The pharmaceutical company Sanofi has stated that “the filing of the corresponding legal resources is currently being evaluated” since they consider the sentence “unfair” compared to other judicial resolutions.

“In accordance with the scientific knowledge on the risks associated with the use of sodium valproate, especially during pregnancy, Sanofi has demonstrated transparency with health authorities and has requested updated medical information for doctors and patients.”

Our assessment

The discrepancy between the data reported by those affected, on the one hand, and the pharmaceutical company, on the other, complicates the clarification of this case.

The pharmacovigilance controls imposed on treatments during pregnancy are very strict, so much so that they have sometimes been accused of excessively reducing the therapeutic arsenal for pregnant women.

The unfortunate precedents with thalidomide and other drugs have taken extreme measures to control treatments in pregnant women to avoid their repetition.

From bioethical criteria it is required that those involved, patients and physicians, in addition to the aforementioned pharmacovigilance controls that must be strict, be provided with all available information on the risks of any treatment, which seems not to have been done scrupulously in this case.

Even uncertain or not fully confirmed data should be published to allow those involved to adopt prudent positions, to avoid cases like the one we are now dealing with.

Respect for the autonomy of the patient demands it, and any attempt to hide data, even those that are not completely confirmed, threatens the free choice of patients and prescribers.

 

Julio Tudela and Paloma Aznar

Bioethics Observatory – Institute of Life Sciences

Catholic University of Valencia

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