The Spanish Agency for Medicines and Health Products (AEMPS) warned this Thursday of the preliminary results of a study that suggest an increased risk of neurodevelopmental disorders in children whose male parents were treated with valproate in the 3 months prior to conception.
The study, noted the AEMPS, has certain limitations whose impact on the validity of the results is still unknown, for which reason the European authorities have requested additional information from the pharmaceutical companies that produce the drug to assess the robustness of the data.
According to the Spanish Agency for Medicines and Health Products, medicines containing valproate and its derivatives are indicated for the treatment of epilepsy and as a second option in manic episodes of bipolar disorder. There are 10 authorized presentations of these drugs in Spain, both in generic form and under the brand Depakine (Sanofi Aventis).
The health authorities indicate that if you are a man or a male adolescent and you are being treated with valproate you should not stop treatment without first talking to your doctor, as the symptoms of your disease could reappear. The possible risks of the drug refer to the offspring, so the recommendation is to assess with your doctor the need to use effective contraceptive measures. In the same way, it also recommends notifying your specialist of your intention to become a father if you are undergoing treatment with the drug.
Teratogenic effects in case of maternal exposure to valproate were already known. In fact, there are preventive measures to avoid maternal exposure during pregnancy. In 2022, the court found a relationship between the neuronal damage of three children and the consumption of this antiepileptic by their mothers, for which reason the manufacturer of Depakine (Sanofi Aventis) was ordered to compensate the affected families.