Neurodevelopmental Disorder Risk: Study Raises Concerns About Valproate Medicines in Fathers
A recent review conducted by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has sparked concerns regarding the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines. Valproate medicines are commonly used to treat epilepsy and bipolar disorder.
The review focused on data from a retrospective observational study carried out by pharmaceutical companies as part of their obligations following a previous review on the use of valproate during pregnancy. The study compared the risk of NDDs, including autism spectrum disorder, in children born to men taking valproate versus children born to men taking lamotrigine or levetiracetam, which are alternative treatments for epilepsy. The study utilized multiple registry databases in Denmark, Norway, and Sweden.
Initial results from the study suggest a potential increased risk of NDDs in children born to men taking valproate in the three months prior to conception. However, the PRAC has identified important limitations with the study’s data. Concerns arose regarding the definition of NDDs used in the study, as well as the specific type of epilepsy patients had. This latter point is crucial because valproate may be prescribed more frequently for certain types of epilepsy associated with NDDs.
Additionally, the pharmaceutical companies involved in the study informed the PRAC about errors discovered in the Norwegian database. The impact of these errors is still unknown. Consequently, the PRAC has requested the companies involved to provide corrected data analyses and additional information promptly to address these limitations.
The PRAC will thoroughly review the required data as it becomes available and subsequently make a recommendation at the European Union level. Meanwhile, some Member States have implemented interim national recommendations while awaiting the PRAC’s evaluation.
It is important to note that male patients undergoing valproate treatment should not abruptly stop taking their medication without consulting their doctor, as doing so could worsen their epilepsy or bipolar disorder. Sudden discontinuation of epilepsy treatment could also trigger seizures. Therefore, patients with concerns about their treatment should speak with their healthcare professional.
Previous recommendations remain in place, advising women to avoid exposure to valproate medicines during pregnancy due to the risk of congenital malformations (birth defects) and neurodevelopmental disorders.
This review of valproate medicines in fathers sheds light on potential risks associated with the use of these medications prior to conception. While further analysis is needed to fully understand the implications, healthcare professionals and patients are urged to stay informed and communicate openly about treatment options and any concerns that arise. The ultimate goal is to ensure the safety and well-being of both parents and their children.
