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.


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