Dear Healthcare Professional communication issued by the HPRA on “fathers exposure” to EPILIM (Sodium Valproate).

Last Updated: Wed, 04/10/2023 – 11:00

Further to our recent updates regarding a European review of data on the potential risk of neurodevelopmental disorders, including autism spectrum disorders, in children fathered by men taking EPILIM (sodium valproate) – containing medicines in comparison to those fathered by men treated with lamotrigine / levetiracetam 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, bipolar, or other medical condition and using Sodium Valproate (Epilim), DO NOT stop taking your medication without first having a discussion with your Health Care Professional. Discontinuing or reducing your anti-seizure medications is likely to lead to the recurrence of seizures or an increase in seizure frequency.

You can download the Direct Healthcare Communication Professional (DHCP) document which was issued on the 15/09/2023 here: https://tinyurl.com/274d2mnr

Further information on this ongoing review regarding paternal exposure to Sodium Valproate can be found here:  https://rb.gy/r0o6w

Due to the catastrophic harm to an unborn baby associated with the use of EPILIM (sodium valproate) in pregnancy, the existing advice is that valproate should not be used in female children and women of childbearing potential. We are calling on the Minister for Health Stephen Donnelly to immediately establish a FULL Disability Pathway of Care for the families harmed.