Preliminary results from a study suggest that children whose parents were treated with the antiepileptic drug valproate in the three months prior to conception may be at increased risk of neurodevelopmental impairment, compared to children whose parents were treated with other antiepileptic drugs. such as lamotrigine or levetiracetam, as reported by the Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is evaluating the results of the EUPAS34201 study, which is retrospective observational and has been conducted in several registries in Scandinavian countries (Denmark , Norway and Sweden). This study, according to the AEMPS, has certain limitations, which is why the PRAC has requested additional information from the pharmaceutical companies to assess the robustness of the data.
In the meantime, and as a precautionary measure, the AEMPS recommends that healthcare professionals inform their male patients who are being treated with valproate and its derivatives of the existence of a study that has not yet been completed, but whose initial data suggest that the Use of these drugs in the three months prior to conception could expose the unborn baby to a possible risk of neurodevelopmental disorders, including autism spectrum disorder (ASD), or congenital malformations in the offspring.
Valproate, indicated for the treatment of epilepsy
Medications containing valproate and its derivatives are indicated to treat epilepsy and as a second option in manic episodes of bipolar disorder. The teratogenic effects in case of maternal exposure are widely known and there are preventive measures to avoid exposure to women during pregnancy, as explained in the safety information notes published by the AEMPS: MUH (FV), 3/2018 and MUH (FV), 10/2018.
“Male patients receiving treatment with valproate “should not stop treatment without first talking to their doctor, since the symptoms of their disease could reappear”
In 2018, after a European reassessment of the benefit/risk balance of these drugs, pharmaceutical companies were asked to carry out various studies to better characterize the risks associated with the use of these drugs, and the objective of one of these studies. is to evaluate the risk of malformation and neurodevelopmental disorders in children whose parents had been exposed to valproate or its derivatives before conception.
The AEMPS has also warned that men or male adolescents who are being treated with valproate “should not interrupt treatment without first talking to their doctor, as the symptoms of their disease could reappear”, and also recommends that patients who are taking When treating with this medicine, talk to your doctor to assess the need to use an adequate contraceptive method and inform him if you want to have a child soon.
Source: Spanish Agency for Medicines and Health Products (AEMPS)
