26-09-2017 | Irish mother to address European Medicines Agency Public Hearing on Sodium Valproate in London

25 September 2017
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'26-09-2017 | Irish mother to address European Medicines Agency Public Hearing on Sodium Valproate in London' image

A Public Hearing is being held today at the European Medicines Agency (EMA) in London to listen to the experiences of women in the EU who have been prescribed valproate-containing medicines for conditions including epilepsy and bi-polar disorder.

Karen Keely, from Co Meath whose three adult sons have been affected by exposure to the drug in the womb will speak on behalf of the FACS Forum Ireland 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.

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

Sodium valproate (brand name Epilim) may have affected at least 400 children with birth defects and developmental issues, since it was first licensed here in 1983. Children exposed to the drug in the womb have a 30-40% chance of serious developmental disorders and/ or physical disabilities in 10% of cases.

Speaking about the effects the drug has had on her and her sons Harry, Lee and Lorcan, 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. Two of my three boys require lifelong care and will never be able to have a normal life. They will never be able to get married or have children. They have been robbed of all the joys of life. None of us want future generations to be affected or ignored in the same way that we have. But if we continue on the same path, that is exactly what will happen.

"In Ireland, the 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 is 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 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 will also attend the Public Hearing on behalf of the FACS Forum said: "Epilepsy Ireland has also conducted a number of surveys 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".

In addition to seeking better risk reduction measures, the FACS Forum is also calling on the government to take action to identify the scale of the problem in Ireland, to assess the complex needs of the families affected and to put in place appropriate pathways for the diagnosis and treatment of FACS

The public hearing will be broadcast live on EMA's website from 12:45 to 18:00 UK time on 26th September. Visit www.ema.europa.eu/ema/.

For more information on the work of the FACS Forum, see www.facsforumireland.org.


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