French pharmaceutical group Sanofi has announced its indictment for “aggravated deception" And "unintentional injuries” in the case of the marketing ofantiepileptic Depakin, at the end of 
an investigation opened in September 2016.
The basic molecule, sodium valproate, has been marketed since 1967 under the brand name Depakin by Sanofi, but also under generic brand names and is also prescribed for bipolar disorder but carries a high risk of injury to the fetus when taken by a pregnant woman .
The investigation aimed to establish whether there had been a liability of the pharmaceutical company consisting in having kept silent about the damages that the use of Depakin during pregnancy could cause.
However, the pharmaceutical company claims that it has always fulfilled its information obligations and has warned the health authorities since the early 1980s of the risks of fetal malformation and since 2003 of the risks of neurological development, but without an immediate reaction by the authorities.
According to a report made by the French National Agency for Drug Safety in April 2017, 
pregnant women given the sodium medicine valproate had a four times higher incidence of births with congenital malformations. The children born with problems would be around 3,000.
The antiepileptic drug is also sold in Italy, but the leaflet clearly states that there are high risks for the fetus and that the drug should not be taken during pregnancy.
Depakin is based on sodium valproate, a substance which exerts its effect above all on the central nervous system. Its main mechanism of action seems to be linked to a strengthening of the gabaergic pathway.
The Lifesaver – February 4, 2020
Depakin, Swissmedic under accusation
A dozen families report the lack of warnings about the side effects of the antiepileptic drug
It is a story that has been shaking France for some time, and which is now also being talked about in Switzerland. It concerns Depakin, a preparation against epilepsy, under accusation because it can cause malformations and serious developmental disorders in the children of women who take the drug during pregnancy. In our country, Depakin, one of the most prescribed antiepileptics in the world, has been authorized since 1972, and for over 30 years it has been known that it can harm the fetus. And yet, "the doctors have never told us anything", say several mothers of children 
born with malformations.
A dozen Swiss families have filed a complaint against some doctors and Sanofi, the French pharmaceutical company that produces the drug. Currently, however, the finger is also pointed at Swissmedic, which in the past would not have sufficiently sensitized the medical profession to the risks of antiepileptic drugs.
For its part, Swissmedic rejects the allegations. In a report drawn up in response to a parliamentary act, the drug control authority ensures that, unlike in other countries, such as France, in Switzerland the medicine has always been administered with great caution. The report speaks of about forty cases of children born since 1990 with malformations, even serious ones, caused by the antiepileptic. According to experts and patient rights organisations, the number of victims could be much higher. In order to shed light on this matter, the Swiss Academy of Medical Sciences is now asking the Federal Council for an external and independent expert opinion.
Related news: Sanofi net income up 7% in 2019
