Dépakine scandal: Maggie De Block announces her measures to avoid « this kind of sad situation » in the future

« I understand the grief and anger of parents who question the use of drugs containing Valproate during pregnancy. My priority is to prevent this kind of sad situation from happening again.It is in these terms that the Minister of Social Affairs and Public Health, Maggie De Block, announced on Tuesday the measures she has taken following questions about drugs containing this dangerous molecule.

For having taken these antiepileptics during their pregnancy, marketed since 1967 by the pharmaceutical laboratory Sanofi under the name Depakine, thousands of mothers have given birth to children suffering from serious developmental disorders. By modifying the expression of genes, sodium valproate has, in fact, generated in 30 to 40% of these children neurological disorders (autistic disorders, psychomotor retardation, language disorders, Asperger syndrome, ADHD, dys disorders, behavioral , hypotonia) and in 10% of congenital malformations (Spina Bifida, heart problems, cleft palate, finger anomalies, club foot/hand, visual disturbances, hyperlaxity, etc.).

A few weeks ago (La Libre of February 6, 2017), we also met Nathalie Raemdonck and her son Robin, one of the four Belgian families who decided to file a complaint in the context of this health scandal.

· If we are, in Belgium, still very far from considering the creation of a compensation fund for victims, as is the case in France, the Belgian Association of Victims of Valproate Syndrome has been fighting since its creation in 2014 on a series of fronts.

· His projects: to diagnose affected children and report them to a referral centre. « By extrapolation with the French and English figures, we had estimated from 3000 to 4000, the number of families concerned in Belgium. Today, while the association has only about seventy families, we know that this number is far from the reality. There are families who only now discover the scandal and the link between Dépakine and neurological disorders, Nathalie Raemdonck pointed out to us. What we especially want to know is « where are the responsibilities? » : the pharmaceutical laboratory that develops the drug; the agency granting marketing authorization; the doctor who prescribes them. I believe everyone is responsible. You had to act like a good father. There were warnings very quickly. We did not see fit to release the information. It is a drug prescribed in particular for epilepsy, bipolarity, and migraine, often effective but with serious side effects.« .

· Another very tough fight led by the association consists in having the embryofetopathy recognized by Valproate, or all the lesions caused in the embryo and the fetus following the taking of this medicine by the mother during pregnancy.

Disseminating information concerning the new prescription recommendations for the drugs concerned and ensuring their application is also one of the objectives pursued by the victims’ association, which also wishes to maintain a link with health professionals, the Agency medicine and the Ministry of Health.

· As well as the continuation of negotiations for the affixing of a visual warning on the boxes of teratogenic drugs (increasing the risk of malformations).

What does Maggie De Block offer today in relation to all this?

At the beginning of July 2016, the Minister for Public Health had requested the opinion of the Commission for medicinal products for human use of the FAMHP, the Federal Agency for Medicines and Health Products, concerning the affixing of a pictogram on teratogenic medicines, such as those containing Valproate. On the basis of this opinion, the Minister has drawn up a series of measures which she communicated to us for the first time on Tuesday:

1. An information campaign.

The FAMHP has been asked to draw up an information campaign concerning the use of medicinal products by pregnant women and women of childbearing age. « This is a campaign that will need to be run every year, as new women, young and old, are involved every time.we explain to the Ministry of Health. This campaign aims to spread the following message: if you are taking medication during your pregnancy, talk to your doctor and your pharmacist and read the leaflet.« .

2. A pictogram

In order to reach as many people as possible who use Valproate-based medicines, it is being examined whether it is possible to affix a pictogram to all medicines containing this molecule, Maggie De Block said. « Consultation is planned on this subject, in particular with the French authorities who have decided to introduce such a measure. We first want to see what informative and educational material will be put in place in France, what are the good practices and where are the possible obstacles for the affixing of such a pictogram. »

3. A European agenda

Finally, the Belgian Minister for Public Health wishes to put the approach to be followed for teratogenic drugs, and more particularly those based on Valproate, on the agenda at European level, in order to arrive at a communication coherent within all the Member States.

Visual warning

On November 28, a meeting was held at the Federal Medicines Agency bringing together various specialists, patient associations and members of the Agency. The discussion concerned the bill concerning the affixing of a visual warning on boxes of teratogenic drugs.