HPRA Drug Safety Newsletter highlights risks of Sodium Valproate

In the latest edition of their Drug Safety Newsletter, the Health Products Regulatory Authority (HPRA) have reminded heathcare professionals on their roles & responsibilities when it comes to prescribing & dispensing the epilepsy drug sodium valproate (epilim). 

The medication is known to have significant risks to the foetus when used in pregnancy. Epilepsy Ireland welcomes the HPRA's decision to publish another valproate-specific edition of their Drug Safety Newsletter which is circulated six times a year to doctors, pharmacists, nurses and other health professionals.

Alongside our colleagues in OACS Ireland, we have campaigned for many years to reduce the risks of sodium valproate for women and girls. While there has been considerable progress made in recent years such as new warnings on the medication, a HSE information campaign for patients and professionals and an end to the practice of 'broken bulk' dispensing, Epilepsy Ireland & OACS Ireland are highlighting that there is still considerable work to be done to further reduce thr risks to women and girls with epilepsy. 

In a recent Epilepsy Ireland survey of women & girls with epilepsy on their awareness of the risks of sodium valproate, there were a number of worrying factors identified - including a lack of awareness about the potential risks of taking valproate and reports of protocols issued by HPRA and the Euopean Medicines Agency not being followed when prescribing/ dispensing the drug. Both Epilepsy Ireland & OACS Ireland met with the HPRA in early March to discuss some of the issues that our survey had highlighted and to highlight further actions that we believe are needed such as the establishment of a stakeholder network to co-ordinate the ongoing national effort to ensure the safety of all those who are taking this medication.

The HPRA's drug safety newsletter is an important and timely reminder to healthcare professionals. We look forward to continuing our work with the HPRA and indeed, all relevant stakeholders on this important issue as soon as circumstances allow.

You can view the HPRA Drug Safety Newsletter here.

Further info on sodium valproate can be found here.

The results of our survey will be published in full as soon as possible.