How to consider pregnancy with valproate? For many women who take Depakine treatment, it is difficult to know what to expect when considering having a child. The Medicines Agency (ANSM) announced on Tuesday the posting of a page on its question and answer site to answer these anxieties. Objective: to limit their exposure to the drug as much as possible.
"This page provides access to information presented according to the pathology for which these drugs have been prescribed (epilepsy or manic episodes of bipolar disorder) and whether the patients are of childbearing age, or whether they wish to pregnancy or that they are pregnant ”, explains the ANSM in a press release. “Practical advice is then offered depending on the situation that concerns them,” she adds.
#Depakine and #grossesse
Find our dedicated page to limit the risk of exposure to #valproate for women of childbearing age
It will be accessible via a QR code which will appear on the box of the drugs concerned by the end of the year 2020https: //t.co/p9irksPv84 pic.twitter.com/02I3QQA08O
A QR code for more information
The molecule in question, sodium valproate, has been marketed since 1967 by the Sanofi laboratory under the brands Dépakine (for epilepsy patients), Dépakote and Dépamide (for bipolar patients), as well as under generic brands.
But, if it is taken by a pregnant woman, it presents a high risk of congenital malformations or developmental disorders (autism spectrum disorders, delay in walking or speech, etc.) for her fetus. The questions / answers page recalls these risks and provides access to existing information documents, in particular the information guide for patients and the patient card.
The ANSM adds that "by the end of 2020", a QR code referring to this page will be printed on the box of the drugs concerned, a measure decided within the framework of the European program for the prevention of pregnancies in exposed women. with valproate.
Exposure of retreating fetuses
In February, the ANSM noted that the number of women exposed to Depakine during their pregnancy had significantly decreased since 2013 but remained too high, in particular for bipolar patients, whereas it is formally contraindicated in pregnant women. in this indication.
Between 2013 and 2018, the number of pregnancies exposed to Depakine and other valproate-based drugs decreased by 79%, from 1,044 pregnancies to 224, and the number of children born from these pregnancies is estimated at 124 in 2018. , against 692 five years earlier, down 82%.
The French pharmaceutical group Sanofi, accused by families of victims of having delayed too long in informing about the risks of taking this drug during pregnancy, was indicted in early August for “involuntary homicides”. The laboratory has already been prosecuted since February for “aggravated deception” and “unintentional injuries”.
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- Pregnancy
- Drug
- Sanofi
- Depakine