Epilepsy drug may alter children’s nerve development if parents take it

Spanish Agency for Medicines and Health Products (AEMPS), depending on Ministry of Healthhas reported preliminary results Study suggesting an increased risk of neurodevelopmental disorders in children whose parents were treated valproate, These results have been compared with those of other parents who were treated with different antiepileptic medicines (lamotrigine or levetiracetam). three months before conception,

He Pharmacovigilance Risk Assessment Committee The (PRAC) of the European Medicines Agency (EMA) is evaluating the results of the retrospective observational study EUPAS34201, conducted in several registries in the Scandinavian countries (Denmark, Norway and Sweden).

PRAC has requested additional information from drug companies to assess the robustness of the data, after finding some limitations whose impact on the results is still unknown.

Preventive Measures

final findings are awaited, such as precautionary measureAEMPS recommends that health professionals provide their information male patient that they are in valproate treatment The existence of a study that is still ongoing whose data suggests that these drugs may be used in the first three months before conception expose the child to the potential danger of neurodevelopmental disorders, Also, health workers have been instructed to assess the need to implement adequate contraceptives.

In a statement, AEMPS also reminded men or adolescents treated with valproate that “Treatment should not be stopped without talking to your doctoras symptoms of their disease may reappear”. Similarly, it also recommends that patients assess with their doctor the need to implement effective contraceptive measures, as well as advise patients who are being treated with the drug to inform their doctor if they intend to have a baby soon.

What is valproate?

Drugs containing valproate and its derivatives are indicated treatment of epilepsy and as another option bipolar disorder manic episode, Teratogenic effect in case of maternal exposure are widely known and there are preventive measures to avoid maternal exposure during pregnancy.

In 2018, after re-evaluation at the European level benefit/risk balance of these drugs, pharmaceutical companies were asked to conduct various studies to better characterize the risks associated with the use of these drugs. One of these studies aimed to assess the risk of malformation and neurodevelopmental disorders in children whose parents were exposed to valproate or its derivatives before conception.

What is valproate related to? drug group e is used fortreatment of epilepsy partial or generalized; Primary generalized epilepsy: convulsive (clonic, tonic, tonic-clonic, myoclonic) and non-convulsive or absence seizures; Partial epilepsy: simple and complex seizures; For the treatment of secondary generalized seizures, and idiopathic generalized and mixed seizures and/or symptomatic generalized epilepsy (West and Lennox-Gastaut). In addition, it is a drug used in the treatment of mania in adults, which is one of the stages of bipolar disorder,


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