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

Shoes To Fit Splints

One of the downfalls of having children with Cerebral Palsy, is finding adequate shoes that can fit over the splint. Both Lauren and Luke wear splints, Lauren 24 hours a day (with maybe 2 hours rest) and Luke wears day splints. We have been attending Orthotics clinics for years now with the kids and we have never been recommended of a place that actually sells shoes to go over splints……We have finally found somewhere. The day I found them I was over the moon, as any parent whose child has cerebral palsy will know how hard it is too find good supportive shoes to go over the splint.

Splints are commonly made out of plastics that can be heated and moulded directly onto the body. They can be produced quickly; however, the plastic is not very strong. As such, splints are usually recommended only when the device is needed for a short time, or when there is not much force placed on the material. So finding shoes that go over the splint , it was like winning the lottery

Laurens Splints and Trainers

Laurens Splints and Trainers

The other thing is that shoes that we do find and normally it is trainers, wear down very easily as sometimes when Lauren is on her frame she will get lazy and drag her legs, scrapping the shoe. We find ourself buying trainers every 6 weeks. So Im hoping these new shoes will last a bit longer.

It is a sport shoe, so its not like Lauren is finally in heels, but it’s a shoe that accommodates the splint. These shoes are called Tomcat Twisters. They are available in all sizes from a childs size 7 to adult size 5 ( in the UK). There is a winter and summer collection and they are available in 4 different colours…. We will be getting the pink :)
The company is called Tomcat and they don’t just do shoes they also do bikes, trikes, chairs and safeguards for beds.

Tomcat Twisters

Tomcat Twisters

Tomcat Website http://www.tomcatspecialneeds.co.uk/products

Cerebral Palsy and Splints

Cerebral palsy is Neurological condition that affect a child’s movement and coordination.
Neurological conditions affect the brain and nervous system.
Cerebral palsy is caused by damage to the brain, which normally occurs before, during or soon after birth. Known possible causes of cerebral palsy include:
• infection in early pregnancy
• a difficult or premature birth
• bleeding in the baby’s brain
• abnormal brain development in the baby

Symptoms of Cerebral Palsy

The symptoms of cerebral palsy vary greatly from child to child and depend on the type of cerebral palsy your child has . Some children have problems walking, while others are profoundly disabled and require lifelong care
Children with cerebral palsy often have other related conditions or problems, including:
• epilepsy
• learning difficulties
• incontinence
• visual impairment
• hearing impairment
• difficulties speaking or understanding other people speak
• delayed growth
• curved spine (scoliosis)
• drooling
How common is cerebral palsy?
It is estimated that 1 in every 400 children in the UK is affected by cerebral palsy. Approximately 1,800 babies are diagnosed with the condition each year.

Outlook

Cerebral palsy is not a progressive condition. This means it will not get worse as your child gets older. However, it can put a great deal of strain on the body, which can cause problems in later life.
There is no cure for cerebral palsy, but a range of treatments can help relieve symptoms and increase a child’s sense of independence and self-esteem. These include physiotherapy, occupational therapy and medication to relieve muscle stiffness and spasms.

What are Casts and Splints?

Casts, splints, and orthoses are all devices that are designed to maintain the body in a certain position. These devices are used to prevent or correct deformities and/or to help children overcome activity limitations, such as difficulties with standing and walking.
Casts are made of plaster or fiberglass, the same materials used to cast broken bones. They may be solid or removable (that is, cut in half down the length of the cast to allow removal for periods of time). Casts are usually applied for periods between 2 and 6 weeks. Sometimes they are removed and reapplied to increase the stretching effect on the muscles when improvement has been observed. This is referred to as serial casting.

Laurens Night Splints

Laurens Night Splints


Splints are commonly made out of plastics that can be heated and moulded directly onto the body. They can be produced quickly; however, the plastic is not very strong. As such, splints are usually recommended only when the device is needed for a short time, or when there is not much force placed on the material.
How do Casts and Splints Work?
Standing With Splints

Standing With Splints


Casts and splints work by applying forces to the body. By encompassing parts of the body and preventing movement, muscles and joints can be stretched. Many muscles cross two joints (for example, the calf muscles cross both the ankle and knee). To exert a stretching effect, either both joints must be held by the device or activities that stretch the joint that is not in the device should be encouraged. Casts and splints can also provide stability to help some children stand and walk. This is the biomechanical explanation for why these devices work.

The forces that casts and splints usually apply are reactive (that is, they prevent movement by resisting the forces generated by the body). However, muscles lengthen more efficiently in response to active forces. New developments in orthotic design are using compressed gas pistons or coiled springs to generate active forces.

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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Wobble Wednesday

Wobbles Wednesday

Another week gone by, 21 days till my holiday.

I’m back at the gym and spinning and trying to go as and when I can. It’s hard fitting it in with the kids, family and more often than not I’m too tired to go in the evening, I just want to watch the soaps :) I’ve been having a lot of seizures lately, which Im not enjoying as they leave me exhausted. The thought of the gym with my body sore and aching from the seizures its so off putting, but I know realistically excercise is the only way to lose weight.

I’ve totally cut out bread, pasta etc as I was finding when I eat them I would get horrendous tummy ache and my stomach would swell up (as if it isn’t big enough) and just cutting them out alone, feels great. I’m conscious of what I eat all the time but I think it can get too much. So I’ve resigned to myself to the fact that after 5 kiddies my body is really not the same. I’m always going to have my muffin top, it’s part of me. I know I have lost inches as my clothes and coat are that little bit looser.
So onwards and upwards it’s about making the right food choices, and if I can fit in 3 sessions of exercise a week, I’m more than happy.

I found a great picture this week and it basically sums everything up for people on that dieting road. Have a great week everyone :)
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