The last few months Janet and I have been so busy with regards to where our National campaign is presently at. For the past year we have been holding meetings with MHRA (Medicines Healthcare Regulatory Agency) about the surrounding topic of Epilepsy mediciations being taken during pregnancy. When we first met with them we explained in depth how bad the present situation is and they agreed with our figures that approximately 20,000 children have been harmed by Epilepsy drug Epilim. There were many things we discussed and are still working on them also but one of the points we raised was for Epilim to be looked at again. A lot of emerging evidence has been reported in the last few years in medical journal papers stating that if a foetus is exposed to Sodium Valproate there is a risk that 40% of the exposed babies could have the chance of developing Neuro Development Disorders (Autism) We expressed that this figure is to high and naturally they also agreed.
INFACT (me and Janet) initiated that a European Review should be held by the European Medicines Agency as Sodium Valproate is sold in Europe and worldwide. Believe it or not they actually agreed to this. The meeting is held under PRAC (Pharmacovigillence Risk Assessment Committee) and this means that all evidence with regards to Sodium Valproate has to be submitted so that every bit of data can be looked at and assessed. Sanofi (drug company) have been ordered to produce all evidence of clinical trials and other information they held before Sodium Valproate was licscensed.
We have been told by MHRA and we both can’t believe this, but never before have a patient group/organisation ever been involved at the European Medicines Agency and PRAC with any drug or health issue. We are representing all women taking Epilepsy medicines in UK and to be told we have set a prescedent, it’s just fabulous. To us we are just mums fighting for our children.
Our involvement with this has been very personal. We have asked all our mums on our database to write down an case studies of what has happened to them, with regards to before they were pregnant to how it affects them to this day. The amount of ladies that got in touch and provided their stories is overwhelming. When I was typing them out, with every case I was in tears. The heartbreak of what the parents have been through, with dealing with their epilepsy to go through pregnancy and then dealing with a poorly child, and cases where people don’t believe what you were saying. Families have had break ups, both parents have had break downs and that is without the lack of help and support within Health and Education. We also comprised a 40 question survey and this survey based on our results backs up everything these case studies have said, total system failure from the MHRA to Department of Health and Drug Company. The date has been set for INFACT and our colleagues (other groups affected by Epilim) in France and Belgium to present all our evidence and this will happen at the end of June. We have also found out this week our INFACT logo has officially been trademarked
Our next meeting is 18th June our Annual APPG with Alec Shellbrooke MP and our colleagues from Thalidomide Campaign Team. This is always a great meeting as everyone that attends MPs etc are all passionate about this cause and all come up with different opinions and advise different routes for us to go down. We also get to catch up with Nick, Guy and Mikey from the Thalidomide Campaign Team. We normally go for lunch and spend a good 3-4 hours together explaining where we are up to. Their advice is imperative to us as they have been through this and won, and so to have them fully backing us, you just can’t get better.
If you are a woman reading this and have taken ANY Epileptic medicine such as
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