Campaign Update : European Medicines Agency Final Decision – Epilim NOT To Be Prescribed for Epilepsy or Bipolar Disorder


Back in June 2013 after the Panorama Documentry “Pills in Pregnancy” aired, very shortly after we were invited to meet with head of Pharmacovigilence Dr June Raine who also featured in Panorama.

It was a very lengthy meeting and we spoke in detail of the whole topic surrounding AEDs in Pregnancy particularly Epilim as whilst taken during pregnancy poses the worst risk to the foetus.  INFACT had previously written to Ministers expressing our need for a public inquiry due to the systematic failure concerning the prescribing of Epilim, we expected it and obviously due to funding were turned down with our request.  We thought about this long and hard, how and where could we get an investigation into the prescribing of Epilim during pregnancy????  We proposed to Dr Raine and her team that this was investigated at the highest level you can get to….. European Medicines Agency, and were delighted when this was sanctioned.


We were told this would be a lengthy investigation as it involved other EU states, but we needed this time to prepare all our evidence…..and we had a lot.  We produced a National Survey, in which MHRA (Medicines Healthcare and Regulatory Agency) had viewed before we submitted it to the public, in which would be used as evidence, and the results of this survey were outstanding.  With every question it proved system failure on all levels and have since been told it was a much needed contributing part of the investigation.

Another big part of our evidence was to hear from our families, what their experiences of taking Epilim was and how it had affected themselves and their families.  Preparing these documents was heartbreaking.  Hearing from other mums how their babies had been affected, the impact it had on their families and also how they felt as mums.  Very tough and distressing, but looking back we are glad we submitted these case studies and yet again there were a lot.

It has been nearly a year now and the Official Results of the PRAC Assessment have come back.



We were always  hopeful it would come back this way, as over the years the evidence with regards to Epilim and Birth Defects has continued to get stronger and stronger.  So as it stands EPILIM (Sodium Valproate) WILL NOT be prescribed to any lady of child bearing age with regards to Epilepsy / Bipolar Disorder and any other condition.  A brilliant result for all those involved.

At our 1st initial meeting with DR Raine and her team we expressed our concern about the reporting system Yellow Card Scheme, how on the form there was no where to report the effects of medication to the baby.  For the last year we have been working with them on this and can now say this has been changed .  The Yellow Card Scheme was initiated following The Thalidomide Scandal and was made available for all Practitioners and Patients to report and adverse side affects of their medicine.  On 25th November we were invited to attend 50th Anniversary of Yellow Card Scheme – an event to celebrate some of the achievements of this scheme but also a chance to discuss how to make it better. IT was a great day and we are thrilled to be involved in such a poignant initiative.

With regards to the prescribing of Epilim in UK it is now upto MHRA, Department of Health and Government to make sure ladies are fully informed of the risks of prescribing during pregnancy.  INFACT are involved with this and we have had meeting after meeting with different departments and health care professionals about this and will continue to do so until the message is loud and clear.

INFACT / FACSA want to sincerely thank each and every parent that gave us their account of how taking Epilim has affected your family.  They were all in great detail and we understand it must have been hard writing this, but you have helped make a difference.  Your voice has been heard and helped change the prescribing of Epilim.

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