Valproate : a woman was treated on five ignores the risks

alexraths/epictura

Published the 25.09.2017 at 18h22

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valproate sodiumgrossessemédicament

The scandal of valproate has not exceeded the French borders – or not enough. In England, a study published in the BMJ shows a high level of ignorance about the risks of sodium valproate, the aed responsible for birth defects and neurodevelopmental disorders in infants exposed in utero. All the ingredients are here for a case similar to that of France broke out in England.

The work was carried out on 2 000 women with epilepsy, aged 16 to 50 years. They show that nearly one patient in five (18 %) ignores the risks of taking this medicine during pregnancy. More than a quarter of patients under valproate reported not having received information on the risks during pregnancy. Most of these women are still of childbearing age.

Kits information

This is alarming, because these risks are high, such as the have learned to their cost many French families. The surrisque of malformations in the fetus exposed is of the order of 10 %. With regard to the neurodevelopmental disorders, the risk is increased by 40 %. The teratogenic action of the drug is indicated since the 1980s.

The BMJ had already carried out similar work in 2016 : the level of information was the same. This suggests that, despite the scandal that broke out in France, patients English have not got wind of these risks.

The associations to the original work called for the implementation of a policy of information to the patients. In February, information kits were published in England after that the EMA (european medicines Agency) has asked agencies national health to enhance the level of patient knowledge. The study shows that 68 % of female respondents have not received these kits.

These results will be discussed this Tuesday at the public hearing on sodium valproate, which was conducted by the EMA. This is the first time that the agency conducts a public hearing during a procedure aimed to re-evaluate the safety of a drug.