40% of children whose mothers took valproate during pregnancy may have developmental delays

2024-01-30 12:51:27

The Spanish Agency for Medicines and Health Products (AEMPS) published a couple of weeks ago a informative note communicating results of an observational study carried out in the Scandinavian countries (Denmark, Norway and Sweden).

Data suggest an increased risk of neurodevelopmental disorders in children and girls whose parents were treated with valproate (Depakine) compared to others antiepileptics (lamotrigine or levetiracetam), in the three months prior to conception.

The final results showed that the proportion of neurodevelopmental disorders in boys and girls whose parents took valproate was around 5% in the group of that drug compared to 3% in the group composed of lamotrigine or levetiracetam.

It is estimated that between 30% and 40% of children whose mothers took valproate monotherapy during pregnancy may present developmental delays.

Valproate or valproic acid is one of the first antiepileptic drugs marketed in Spain, although today it is also used as a euthymizer (mood stabilizer) in patients with bipolar disorder.

It belongs to a large family of therapeutic compounds that also include phenytoin, carbamazepine, the popular benzodiazepinespregabalin, gabapentin, levetiracetam or topiramate.

Despite such tremendous damage in childhood, the drug does not retire. To minimize or avoid this potential risk, new recommendations have been introduced for the use of valproate in men that must be ratified by the European Commission.

This information will be included soon in the technical sheets and leaflets of the medicines with valproate and information materials on risk prevention will be developed and distributed to help healthcare professionals and male patients understand and manage this risk.

Photo by Anastasia Shuraeva.

Recommendations for health professionals:

• It is recommended that treatment with valproate in men be initiated and supervised by a specialist in the treatment of epilepsy or bipolar disorder.
• It is important that healthcare professionals:
  • Inform men currently receiving valproate treatment of the potential risk of neurodevelopmental disorders in their children conceived during treatment or up to three months after stopping treatment, and consider whether valproate remains the most appropriate treatment.
  • Assess with male patients the need to implement contraceptive measuresincluding for your partner, while using valproate and for at least 3 months after stop treatment.
  • Inform male patients about the need for periodic reviews by your doctor to evaluate whether valproate is still the most appropriate treatment and to discuss treatment alternatives. This is important if the patient plans to conceive and, in this case, before stopping contraception.
  • Advise men to they don’t give sperm during treatment with valproate or for at least 3 months after discontinuation.
  • Provide men on valproate with the guide and warn them about the patient card that will be with their medication container.

And here’s the news because these damages have been known for years. In fact, in Francethe manufacturer of this drug, Sanofi, had to compensate three people for the damage caused to them: malformations in fetuses of pregnant women.

The amounts with which the pharmaceutical company had to compensate its victims were from 600,000 euros to 1,300,000.

This is documented by a ruling made public by the Association of Victims of Valproic Acid Syndrome (AVISAV), who recalled that the teratogenic effects of the drug have been known since 1980, when it was described that intrauterine exposure to the Valproate caused alterations in the closure of the neural tube (spina bifida) in children.

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