Further to our recent updates regarding a European review of data on the potential risk of neurodevelopmental disorders in children conceived by fathers who are taking Sodium Valproate, we can confirm a ‘Dear Healthcare Professional’ communication has been issued by the Health Products Regulatory Authority (HPRA) to clinicians across Ireland regarding this ongoing review.
A Direct Healthcare Professional Communication (DHPC) aims to promote safe and effective use of a marketed medicine and aims to ensure that clinicians have the most up to date information possible about a medication. The communication is delivered directly to healthcare professionals by manufacturers of the medication or by regulatory authorities such as the HPRA.
It is important to note that the issuing of the DHCP does not mean the ongoing review has concluded or that the findings of the initial study can be seen as definite.
The review is ongoing at European level and as soon as we have any further update on this matter, we will provide details of this on our website. We also remain in close communication with the Irish regulators, the HPRA, regarding this ongoing review.
In the meantime, if you are a man with epilepsy taking Sodium Valproate (Epilim), DO NOT stop taking your medication without first having a discussion with your medical team. Discontinuing or reducing your anti-seizure medications is likely to lead to the recurrence of seizures or an increase in seizure frequency.
The DHCP which has been issued on this ongoing review can be read and downloaded at the end of this article.
Further information on this ongoing review regarding paternal exposure to Sodium Valproate can be found by visiting the ‘News’ section of our website.