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of everyone affected by epilepsy

 

Sodium valproate campaign

What's the issue?

Sodium valproate is a medicine used to treat epilepsy. It is often prescribed under the brand name Epilim. For some people it might be the most effective epilepsy medicine. However, if sodium valproate is taken during pregnancy it can cause birth defects and developmental problems in babies.

It is crucial that women do not stop taking their medication if they think they are pregnant before talking to their healthcare professional first.

A recent survey by Epilepsy Action, Epilepsy Society and Young Epilepsy, show that one in five (18%) women taking sodium valproate are unaware that taking it during pregnancy can harm an unborn baby.

Epilepsy Action believes that all women who are prescribed sodium valproate must be made aware of the risks. We also believe that all women with epilepsy should receive pre- conception counselling. More needs to be done to ensure that healthcare professionals are given the right time and resources to talk to women and girls with epilepsy about pregnancy. Ideally, they must know about the associated risks before they conceive.

On 24 April 2018, the Medicines and Healthcare produces Regulatory Agency (MHRA) changed the licence for valproate medicines in the UK. Sodium valproate must no longer be prescribed to women or girls of childbearing age unless they are on the pregnancy prevention programme (PPP).

As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. They must also understand the need to take contraception while on the medicine. A risk acknowledgement form must be completed and signed during a review that must take place at least once a year.

What we are doing 

The MHRA will be putting in place more things to make sure all women taking sodium valproate are aware of the risks. We are working closely with them to make sure this information is good and that it is given to the right people. This includes the development of a toolkit for healthcare professionals and patients.

View the toolkit

We want to make sure that every women who is prescribed sodium valproate is aware of the risks. We will work with other epilepsy charities and the MHRA to monitor how the new regulations and the toolkit are working.

We want all women and girls of childbearing age with epilepsy to receive pre-conception counselling. We are asking the National Institute for Health and Care Excellence (NICE) to reintroduce pre-conception counselling as a Quality Outcome Framework (QOF) indicator.

How you can get involved 

We will be running a survey later in the year to monitor how well these new regulations are working. If you want to take part, then keep watching our page and social media for updates.

We want to hear your story. If you have been affected by any of the issues discussed, then please email campaigns@epilepsy.org.uk

It is crucial that women do not stop taking their epilepsy medicines without talking to a healthcare professional first. Stopping your medication could be harmful for you, and if your pregnant, your unborn child. If you are worried about any of the issues discussed then please make an appointment with your doctor. For information on planning a baby for women with epilepsy please contact the Epilepsy Action Helpline on Freephone 0808 800 5050.

Event Date: 
Sunday 12 October 2014 (All day)

Comments: read the 8 comments or add yours

Comments

As a male taking epilim (sodium valproate) since I was 7 and now 50 years of age, could this drug effect my unborn child also and is there any cases of this.

Submitted by Andrew Pearmain on

Hi Andrew

Thankfully, when it’s the father taking sodium valproate (or other epilepsy medicines) it does not affect the baby’s development.

Regards

Diane

Epilepsy Action Helpline Team

Submitted by Diane-Epilepsy ... on

I have been taking Sodium valproate since I was 25. My daughter was born with spina bifida and hydrocephalus, my two sons are both healthy. I have just read of a study suggesting the possibility that problems can be passed down to another generation. Is this something my sons should be aware of or could it only be passed on through my daughter? My daughter and younger son are twins.

Submitted by Kathy Anderson on

Hi Kathy

There is some new research to suggest that this could be passed down through generations. But the research is still at a very early stage, and it has only been conducted on mice. There would need to be a considerable more research before there was any certainly about this happening.  

Here is our general information about epilepsy and inheritance.

Hope that helps.

Regards

Cherry  

Epilepsy Action Helpline Team

Submitted by Cherry-Epilepsy... on

Hi I've been taking epilim for 30 plus years and was taking it through both my pregnancies my daughter was born in 1992 without a thyroid gland and an abnormal gait we discovered 2 years later she also had learning difficulties as her speech did not develop, my son was born in 1994 and when he was 4 was diagnosed with autism and learning disabilities. I am now at the stage were it's a constant fight for anything for them when it comes to benefits or support from social care, because the warnings were not there when I took the drug, if they had been I could of taken different actions or at least been prepared.

Submitted by Cheryl lovelle on

in 1989 when i was 19 i started having seizures at night i was sent to a specialist who after brain scans put me on Epilim tablets (sodium valproate) a month later when i went to see him i mentioned that i had just found out i was pregnant he went mad and said "if i had known you were going to get pregnant i wouldnt have put you on this medication" i was shocked at his reaction and said you never said anything about this medication effecting a pregnancy when you prescribed them to me. then when i went for my 12 week scan i was told my baby had died 4 weeks into my pregnancy but bag was still growing. (which was around the time i started taking this tablet). i had to have a scrape operation to remove everything. i refused to ever see a epilepsy specialist ever again. then fast forward to march 2018 my nephew who also has epilepsy was seeing his specialist as he was being weaned off Carbamazepine while introducing Lamotrigine his specialist decided to add a additional tablet Clobazam and 3 days later he died age 24

Submitted by rachele graves on

Dear Rachel

I was so very sorry to read about the two losses you have experienced. Each of them sounds really traumatic.

Certainly the information about sodium valproate in pregnancy, and the urgency attached to that information have increased over the years. The current guidance, as you may have seen, is that it is never prescribed for a woman with epilepsy of child bearing age unless there is a really good reason for this.

I wonder how you are doing now in terms of seizure control? If you are still having problems I do hope you’re at least able to talk with your GP about this. And maybe they could be in touch with a specialist or even an epilepsy nurse. You might find it easier to talk to a nurse possibly.

The death of your nephew must have been such a shock for you. I wonder if his death was possibly epilepsy related? If so it may be helpful for you or other members of your family to look at our information on epilepsy-related deaths. And then you may want to contact SUDEP Action. They run a helpline especially for people who have lost someone due to epilepsy.

Thank you for sharing your situation with us. I really hope things start to feel just a little easier over time. 

Kind regards

Cherry  

Epilepsy Action Helpline Team

Submitted by rich on

After reading numerous comments about Sodium Valproate it is so sad to see that Sanofi are still being allowed to manufacture this drug!

I was commenced on this drug over 25 years ago and have two children, aged 15 and 11 now. My daughter was born with no difficulty or abnormalities however, the same cannot be said for my 11 year old son.

I gave birth to my son in 2007 to what I believed was a healthy baby boy however, as time progressed he was diagnosed with bony abnormalities in both arms by a specialist children's hospital where he became, lets say a child of Consultants interest (every visit there where numerous doctors due to this rare condition I was told) After months of discussion he underwent intense surgery and skin grafts to try to gain radial movement in wrist and elbow joints due to fused bones. Unfortunately this was not very successful.

After all this time I have just been asked to be reviewed urgently by my GP, referred to a Neurological specialist at a specialist hospital and given numerous information packs about the risks and dangers about taking this drug if becoming pregnant.

It is disgraceful that a company can manufacture such a harmful drug and that it is still considered to be the number one drug of choice for people with epilepsy when the side effects and statics of abnormalities and even deaths in unborn children is so high !

Submitted by Clare H on

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