Public Hearing at the European Medicines Agency (EMA)

A Public Hearing was held at the European Medicines Agency (EMA), London on 26 September 2017. The hearing is part of a review by EMA, the second in just three years, looking at the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age. In 2014, the Agency put in place measures across Europe to strengthen the warnings and restrictions on the use of the drug in women and girls, due to the risk of malformations and developmental problems in babies exposed to valproate in the womb.

Karen Keely, whose three adult sons have been affected by exposure to the drug spoke on behalf of the Forum and on behalf of a growing number of Irish families who have come together to campaign for greater awareness of the issue and supports for families affected. Karen said:

“This is an important and emotional day for me and many Irish families who have struggled for years to have our children’s disabilities recognised, diagnosed and treated. My family are living evidence of the risks and the devastating impact of this drug.

“In Ireland, the Health Products Regulatory Authority (HPRA) and HSE have taken some measures to improve awareness of the risks and to improve communication between patients and health professionals, these have largely been tick-box exercises with little regard for delivering real change. The response has been unsatisfactory and there have been no efforts made to address the needs of families already affected.”

The public hearing was held in response to ongoing concerns regarding the effectiveness of the 2014 measures and to consider whether further EU-wide action should be recommended to minimise the risks for women taking the drug. This will be the first time the EMA’s safety committee – the Pharmacovigilance Risk Assessment Committee (PRAC) – has held a public hearing to review the safety of a medicine.

Last week, data released by three UK epilepsy charities[1] found that almost 70% of women taking the drug had not been given adequate information while over 20% they had not had a discussion initiated by a healthcare professional about the risks.

Epilepsy Ireland CEO Peter Murphy who also attended the Public Hearing on behalf of the FACS Forum said: “Epilepsy Ireland has also conducted a number of surveys[2] of women taking valproate and found that while doctor-patient communication is improving since 2014, still only 56% of women surveyed last December say that have had discussions on this issue with their healthcare professionals and 1 in 5 were still not aware of the new restrictions in place since 2014.

“A lot more needs to be done. Measures to reduce risk must be outcome-driven and measurable. The use of valproate information resources should be mandatory and informed consent should be obtained when using the drug in women and girls. A valproate register should be established and properly resourced public awareness campaigns need to happen. Warnings must be displayed on the external packaging of the drug and importantly, medication should not be dispensed without original internal and external packaging”.

The EMA is to report on its findings over the next couple of months.

You can watch the Hearings here. Karen Keely’s contribution is approximately 45 minutes into the recording.


Hospital Saturday Fund grant awarded to the FACS Forum

September 2017

We are delighted to receive a grant from the Hospital Saturday Fund to support awareness raising around FACS. Joan O’Donnell, Chair of the Forum, and Development Manager with the Disability Federation of Ireland, accepted the grant on behalf of the Forum on 22 September form Paul Jackson, CEO of the Hospital Saturday Fund. This grant will go a long way to resource awareness raising with both parents and healthcare professionals about this issue. It will also contribute to developing international links with other organisations supporting families across Europe.

Picture: Geoff Day, Karen Keely, Paul Jackson, Joan O’Donnell, Jimmy Dunne, Beverley Dunne.



June 2017 – The Pharmacovigilance Risk Assessment Committee (PRAC) has set a date for a public hearing

June 2017

The Pharmacovigilance Risk Assessment Committee (PRAC) has set a date for a public hearing on the use of Valproate.

The PRAC decided it will hold its very first public hearing on 26 September 2017 at the Agency’s premises in London. They will discuss the safety review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. EU citizens will be invited to share their experiences with these medicines so that this can be taken into account in the Committee’s recommendation.

PRAC plans to issue further information at the beginning of July.

This is the first time the PRAC will hold a public hearing during a safety review of a medicine. It follows the adoption of rules of procedure on the organisation and conduct of public hearings and a simulation training in 2016.

The FACS Forum welcomes this news and we plan to be represented at the public hearing.

May 2017: The New Epilim Packaging

HPRA has approved the update and Epilepsy Ireland understands the updated packaging (see image below) will be introduced to the market within the next few months. The FACS Forum welcomes this news. We have been actively campaigning for this for the last year since the HRPA made a commitment to change the packaging in May 2016.

The new warning on boxes of sodium valproate (Epilim)