European Review into Sodium Valproate

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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
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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
Phenytoin
Ethosuximide
Carbamazepine
Valproate
Lamotrigine
Topiramate
Zonisamide
please spare a few moments to fill in our survey https://www.surveymonkey.com/s/ZDSDNDV

Epilepsy, Pregnancy and Pills Campaign

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Epilepsy medications (AEDs) are not only used to treat Epilepsy but also used for a variety of different illness such as
1. Migraine
2. Pain Relief
3. Depression
4. Bipolar Disorder

With regards to treating the illness they can be very good, however fatal whilst taking these medications during pregnancy. These medications when taken during pregnancy can be harmful to the foetus as the medicine passes through the placenta. It is now a known fact that the medicines listed can affect the baby. Not all babies are affected by this and some babies are born healthy. It is dependant on dosage and also the womans metabolism

Phenytoin
Ethosuximide
Carbamazepine
Valproate
Lamotrigine
Topiramate
Zonisamide

The medical diagnosis and umbrella name of when theses medications affects the baby is known as FACS (Fetal Anti Convulsant Syndrome)

Fetal Carbamazipine Syndrome – Carbamazipine was liscensed in 1965 and has been on the market for 48 years. It is estimated that around 15000 children are affected each year and estimates since it being on the market 60,000 children have been affected

Fetal Hydantoin Syndrome – Phenytoin was liscensed in 1938 with an approximation of 200 children are affected each year. since it being on the market estimations are predicted that around 8000 children have been affected,
Fetal Valproate Syndrome

Symptoms of FACS are : Sodium Valproate (Epilim) was introduced in 1973 and was predominantly prescribed for Epilepsy, however it is now used for different illnesses. Our campaign estimated along with MHRA (Medicines Healthcare Regulatory Agency) that an estimated 20,000 persons have been affected by Epilim with 500 babies born per year and is still ongoing. All these medications are still being prescribed on a daily regular basis and also for other things, however as our National Survey shows the knowledge and understanding of these drugs is not being told to the people that matter ….the patient.

Symptoms of FACS

• Premature Birth
• Small fingernail
• Spina Bifida / Cerebral Palsy
• Limb defects
• Joint Laxity
• Characteristical facial features
• Delay in reaching milestones
• Gross and fine motor skills
• Autistic Spectrum Disorders
• Speech and Language Delay
• Attention and memory difficulty
• Vision problems
• Incontinence
• Inguinal Hernia
• Hypospadias
• Bowel Problems

http://en.wikipedia.org/wiki/Fetal_hydantoin_syndrome
http://en.wikipedia.org/wiki/Carbamazepine

downloadEpilim – Sodium Valproate

Carbamazepine CR - Taj Pharmaceuticals Limited 0 (2)Tegratol – Carbamazipine

image_139_enEpinuitin – Phenytoin

lamictalLamotrigine

Topiramate Tablet_ Taj Pharmaceuticals Limited 0Topiramate

NICE Guidelines 2012 : http://www.nice.org.uk/nicemedia/pdf/TA076fullguidance.pdf

The older antiepileptic drugs have the potential to interact
with numerous drugs. Carbamazepine, phenytoin and
barbiturates induce hepatic enzymes. This means that they
can accelerate the metabolism of drugs that are metabolised
by these enzymes and higher doses will be needed or the
drugs will be less effective. For example, carbamazepine,
phenytoin and barbiturates reduce the effectiveness of oral
contraceptives, necessitating the use of alternative methods,
or special high-dose regimens of oral contraceptives, the
effectiveness of which is less certain. Sodium valproate is a
hepatic enzyme inhibitor and therefore slows the
metabolism of some drugs, but it does not interfere with oral
contraceptives.
2.13 The effects of these drugs on the unborn child are also a
matter for concern. All the older antiepileptic drugs have
been associated with malformations (see Section 4.1.15).
Multiple drug therapy is associated with a greater risk,
although this may be related to the severity of the mother’s
epilepsy. The Summary of Product Characteristics for sodium
valproate (Epilim) recommends that women of childbearingpotential should not be started on sodium valproate without
specialist neurological advice, and that for partial seizures
sodium valproate should be used only in women found to be
resistant to other treatments.

Janet who I run the campaign with recently wrote a medical journal that was approved in Midwifery Digest. To read click on the link
Knowledge & Understanding of the dangers of AED’s in pregnancy J Williams

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