FACS Forum encouraged by European Medicines Agency’s latest measures on Sodium Valproate in pregnancy

The FACS (Foetal Anti-Convulsant Syndrome) Forum Ireland, an umbrella of patient and disability organisations has welcomed today's report by the European Medicines Agency (EMA) outlining new measures to be taken across Europe to reduce the risks of the drug sodium valproate (Epilim) in women and girls. The Forum is calling for the urgent full implementation of the measures in Ireland.

Sodium Valproate is used in the treatment of epilepsy and bipolar disorder and is associated with a significantly increased risk of malformations and neurodevelopmental problems in babies who are exposed to the drug in the womb.

The FACS Forum estimates that the drug has affected at least 400 children with birth defects and developmental issues in Ireland. The latest HSE data shows that as of July 2016, there were almost 1,700 women in Ireland between the ages of 16 and 44 in receipt of sodium valproate under the GMS, Drug Payment Scheme or Long Term Illness Scheme.

  • In particular, the FACS Forum welcomes the following measures announced today by the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA:
  • A new pregnancy prevention programme to support individual decision making; provide counselling and ensure annual treatment reviews.
  • New visual warnings on outer packaging, including the use of pictograms
  • The increased role of pharmacists in ensuring patient safety, through the use of a new reminder card each time the medicine is dispensed

Joan O'Donnell, Chairperson of the FACS Forum said:

"The measures announced today are a positive step forward in reducing the risk of future valproate-related disability in Ireland and across Europe, and add to the existing risk-reduction measures that have been in place since 2014. The focus must now be on urgently implementing these and other measures in Ireland and we look forward to working with the Health Products Regulatory Authority (HPRA) and other stakeholders in making this happen as soon as possible".

However, the Forum is also concerned that a number of important risk minimisation measures proposed by the group during the extensive European-wide multi-stakeholder consultation process in 2017 have not been clearly identified in today's report.

Peter Murphy, Epilepsy Ireland CEO said:
"At the moment, it remains ambiguous how some of the proposed measures differ from those already in place which have not been fully effective, especially in relation to the dissemination and use of educational materials. It is also unclear if or how the relevant authorities will be tasked with independently ensuring the new measures are effective, rather than this remaining the remit of the pharmaceutical companies. Other priorities such as the need to use brand names in public communications and the urgent necessity for this medicine to be dispensed in properly labelled packaging rather than in plastic bags are not addressed. These are points we have been highlighting for some time and we look forward to discussing our concerns next week with HPRA and other stakeholders".

In addition, the Forum is calling for a range of other actions to be proactively taken in Ireland to reduce future incidence of FACS and to better support the individuals and families already affected:

  • Conduct a national epidemiological study to identify individual cases of diagnosed and suspected FACS.
  • All women of childbearing potential currently taking valproate and under GP-only care should be given priority referrals in 2018 to a specialist in epilepsy/ bipolar disorder for an urgent treatment review
  • Establish nationally maintained registers for women prescribed with Valproate and of children affected by FACS
  •  Put in place streamlined diagnostic pathways for cases of suspected FACS via Clinical Genetics or other appropriate services in order to close the diagnostic gap.
  • ·Undertake an audit of the needs of individuals & families affected by FACS and of the services/ supports provided to them
  •  Establish an independent investigation or inquiry into the historical use of Valproate in Ireland

Karen Keely, Chairperson of OACS (Organisation for Anti Convulsant Syndrome) Ireland and mother of three adult children affected by FACS said:

"While we welcome today's developments, especially visual warnings on boxes and pregnancy prevention plans, we must not forget the impact that this drug has already had on hundreds of children and families in Ireland over the past four decades. These tragedies did not have to happen and the families affected deserve justice in the form of both appropriate care services and compensation for the harm that has been caused". 

The EMA report follows a year-long, multi-stakeholder review of EU-wide risk minimisation measures that were initially introduced in 2014 to strengthen the warnings and restrictions on the use of valproate medicines in women and girls.

The FACS Forum consists of The Disability Federation of Ireland, Epilepsy Ireland, OACS Ireland, Medical Research Charities Group, Migraine Association of Ireland, Shine, and the Genetic and Rare Diseases Organisation.

 Anyone with concerns about valproate should contact their medical team, or Epilepsy Ireland (info@epilepsy.ie; 01 4557500) or OACS Ireland (oacsireland@gmail.com) but under no circumstances should patients stop taking medication without first speaking with their medical team.