European regulators reanalyzing valproate study linked to neurological disorders in children
Following the lead of other regulators in Europe, the Swiss Agency for Therapeutic Products (Swissmedic) says it is investigating whether the use of the drug valproate by fathers is tied to neurological birth defects in their children. In the meantime, the agency says patients should continue using the medication and talk to their doctor if they plan on conceiving.“Various regulatory authorities are currently evaluating data on the potential risk of neurological development disorders in children conceived by fathers taking valproate,” said Swissmedic in a 24 August notice. “As a precaution, Swissmedic is revising the medicinal product information for products containing valproate in order to warn men of the potential risks of this active substance to the unborn child.
“Those affected should under no circumstances discontinue their treatment without consulting their doctor,” the agency added.
In 2018, the European Medicines Agency (EMA) commissioned a retrospective study of valproate, which is used to treat epilepsy and bipolar disorder, compared to the epilepsy drug lamotrigine and levetiracetam. While initial data from Sweden, Norway and Denmark indicated a causality between use of valproate and a risk of neurodevelopmental disorders (NDD) in children whose fathers used the drug during conception, researchers are reanalyzing the data after a number of concerns were raised.
EMA recently issued a similar statement saying it was reanalyzing the data due to concerns about how the study was conducted and conclusions were drawn.
“In particular, the [Pharmacovigilance Risk Assessment Committee (PRAC)] had questions about the definition of NDDs used in the study and the specific type of epilepsy the patients had,” said EMA in a 16 August notice. “The latter is important because valproate may be prescribed more often for some types of epilepsy which are associated with NDDs.
“In addition, after submitting the study results, the companies informed the PRAC about errors in the Norwegian database; the impact of these errors is not yet known,” the agency added.
Similarly, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is also waiting for a reanalysis of the valproate study and cautioned men considering having children to not stop taking their medication before speaking to their doctor.
“The government’s expert scientific body, the Commission on Human Medicines (CHM), has advised that further guidance in respect of risks in children of men taking valproate should be based upon data that are accurate and complete,” said MHRA in a 16 August notice. “As soon as the revised study analysis is available, it will be carefully re-assessed by the MHRA.
“Any further guidance will be communicated to patients and healthcare professionals as soon as possible,” MHRA added.
Swissmedic notice
EMA notice
MHRA notice
