Sodium valproate, the active ingredient of Depakine and an antiepileptic known to cause serious problems in children whose mothers were treated while pregnant, could also pose risks if taken by the father, a warned Thursday, August 4 the drug agency.
There is a “potential risk of neurodevelopmental disorders in children whose father was treated within three months before conception”, writes the National Medicines Safety Agency (ANSM) in a letter to caregivers. But, for the time being, there is no data allowing to draw conclusions. “final conclusions”, specifies the agency. She advises doctors to consider other treatments, but also urges patients on valproate not to stop the drug on their own, or their symptoms may return.
A risk, if proven, much lower than on the maternal side
Sodium valproate is an antiepileptic whose risks for the child – malformation and developmental disorders, such as autism – are already well known if taken by the mother. In its antiepileptic use, it is notably marketed under the name Dépakine by the large French company Sanofi, which has been targeted in this case for several years by multiple legal proceedings, some of which also involve the ANSM. The molecule is also used in the treatment of bipolar disorders, under the names Depakote and Depamide.
The ANSM now applies the precautionary principle by calling on caregivers to be vigilant before more in-depth studies confirm or not the risk of developmental disorders in a child whose father has been treated with sodium valproate.
The agency is based on a study commissioned by its European counterpart, the conclusions of which it had already made public in May. This study, carried out retrospectively on public health data in several Scandinavian countries, and which therefore does not constitute a clinical trial, highlights a higher proportion of mental and/or motor development disorders in children whose father took valproate within three months of conception. The study had estimated a risk of about 6%, against about 3% in children of fathers treated with other antiepileptics, Lamotrigine or Levetiracetam.
But “The limitations of this study do not allow us to conclude on this risk at this stage”according to the ANSM, which also recalls that, even proven, the risk would be much lower than for children whose mother took valproate during pregnancy (between 30% and 40%).
To find out to what extent this risk really exists, the European Medicines Agency has requested additional studies from the pharmaceutical groups that market this treatment.