Epilepsy Ireland News
17|02|2017| The Invisible Victims
For over three decades in Ireland the medication sodium valproate has been used by pregnant mothers to treat their epilepsy. Epilepsy Ireland spoke with two families who believe this drug has led to physical and development issues for their children.
For the past 15 years life has been a struggle for the Dunne family. Their youngest daughter Zoe needs so much attention that her mother Beverly quit her job as a secretary and husband Jimmy was forced to alter his working hours as a chef. Shortly after she became pregnant for the first time Beverly was diagnosed with epilepsy and prescribed three types of medicine, one of which was valproate, known to many by the brand name, 'Epilim'.
In 2014 The European Medicine Agency (EMA) decided to strengthen warnings on the use of valproate in women. A number of studies found developmental problems in up to 40% of young children exposed to valproate in the womb. These problems included delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability. Previous studies also found that children exposed to valproate in the womb were at increased risk of autism, ADHD and malformations such as cleft palate at birth.
"The second I noticed a physical difference, I knew it was because of the epilepsy medication that I was taking", said Beverly.
Zoe began to walk at 2½ years old and as well as having memory and concentration problems she is still exceptionally short for a 15 year old and has crooked fingers (see picture below) which create daily challenges.
Beverley explains: "When I became pregnant with Zoe I was immediately worried. I asked my doctor would my epilepsy tablets harm my pregnancy and he said he would have to increase my dosage. I listened to his advice as my condition was getting worse. Since Zoe was born we have been going to numerous doctors to find out what was wrong."
The Dunne family, who live in Tallaght, say they believe their medical team have not always been fully open with them about the true effects of valproate.
She continues: "Even back then I said to our doctor 'I think it's my medication' and he told me 'we have never heard of any tablets affecting a child'.
Doctors kept saying it was 'Neuro Developmental Delay'. Talking to them has felt like banging your head against a brick wall."
Despite their troubles the family bond is strong and Beverley says older brother Conor (19) is always protective of his younger sister. Jimmy believes a lack of information before the internet era is one of the reasons why families were unaware.
"Back then you would rely solely on doctors' advice but we quickly realised there was something wrong. If they (the doctors) knew the tablets did this to Zoe they should have provided us with extra help from the start. We've been on our own."
Zoe's education has been a constant battle for the Dunne family – she was bullied in her first secondary school with little sympathy or understanding from the teachers.
Jimmy recalls: "The second school she went to was a lot better but the teachers noticed that Zoe was not paying attention in class. We then had to organise a meeting with the principal and teachers revealing our whole story and all the difficulties. They were brilliant, so understanding."
Beverly's fears and suspicions were confirmed when she watched a 2013 BBC Panorama investigation called 'Pills and Pregnancy' which highlighted the valproate issue in Britain.
"A friend of mine Karen Walsh just happened to share the programme link on Facebook one evening. Myself and Jimmy sat down and watched it and he said to me 'oh you were so right'."
Karen Walsh is Ireland's most vocal advocate on the issue – she has three children who have been affected by exposure to valproate during pregnancy. Along with Epilepsy Ireland and a range of patient and representative groups, Karen is heavily involved in the FACS (Fetal Anti Convulsant Syndrome) Forum Ireland.
FACS Forum advocates for better warnings and information from the Department of Health, HSE and the HPRA on the side effects to expectant mothers of drugs that contain valproate. The Forum is also seeking better rights and supports for those families in Ireland who have been impacted by the use of valproate in pregnancy.
As well as providing support for the Dunnes, Karen has also helped another Irish mother who was willing to speak Epilepsy News anonymously. She believes both her children, who were born in France, have been affected by valproate, especially her son. To protect her identity Epilepsy News are using a false name – 'Mary'.
"I only found out last February that valproate did this to my children", Mary said.
"My ex-husband sent me information from France about why I might be having problems. When I found out, I was absolutely shocked and appalled that my children have a disability that could have been prevented – it's an absolute disgrace! For twelve years I've been told lies. I'm so worried about the future of my kids."
In France it is alleged that 10,000 pregnant women were prescribed valproate despite the known risks of it causing serious birth defects. Parents of those affected say the French state and Sanofi (the company who make valproate) were too slow to warn of the side effects of the drug, which has been used to successfully treat epilepsy since 1967, after the risks to foetuses became clear by the early 1980s.
Last November, France set up a fund to meet potential compensation claims from affected families. The French parliament voted to create a nationwide compensation fund and amended its 2017 budget to set aside an initial 10 million euros for claims relating to Depakine, the French brand name for valproate, which is also used to treat bipolar disorder.
Mary continues: "Sanofi don't want to admit any liability but the mothers in Ireland and France will not give in. We're being made the invisible victims. This is a disability that could have been avoided if the communication and information were given to the parents. The children in Ireland who are affected by this, need to get the services and support in place so they can lead a good life. My children need access to services now and not tomorrow, due to their disabilities I had to give up my full time job as they need me more and childcare was not catered for my sons meltdowns, outbursts and hospital appointments."
Like the Dunne family, Mary is visibly upset when recounting her story but is now committed to finding answers. She believes a critical mass of parents needs to come forward and tell their story in order for the Irish Government to act.
"More mothers in this situation need to speak up and acknowledge something is wrong with their child. Massive credit must be given to Karen for bringing the mothers together. This is a medical scandal that should never have happened and the HSE need to get their act together as well..
The Dunne family also echo Mary's sentiments as Beverly stresses the point that it's very difficult for mothers to speak out.
"Many are afraid to tell their story as they don't want to reveal there is something wrong with their child. As a mother you do feel a large amount of guilt. We would like to call on other families who might have the same issue to investigate it and to get in touch. The more people that speak up the stronger our case will be. This medical scandal is one that should never have happened, but has, due to this negligence and non-communication, the HSE and other services need to act and commit for this disability to be diagnosed immediately, so support can be put in place for the parents and the children who suffer daily, as clearly this is a disability that could have been avoided."
In a final impassioned plea a visibly upset Beverly tells Epilepsy News: "The truth needs to come out because this has been a very long hard road. I don't know what Zoe is going to be like when she's in her 20s and later on in life. Mothers need to be warned by their doctor if they are on epilim. These days I feel that you don't know what you're taking.
"Doctors are afraid to discuss this issue. They don't want a big explosion. If France have admitted it, what will be outcome here for our children and the future of our children? We can't just keep hiding the truth - it's not going to go away."
If you are a Mother whose child may have been affected by taking valproate during pregnancy please contact the FACS Forum (Joan) on 01 454 7978 or email Epilepsy Ireland – email@example.com
Find out more about the use of Valproate in pregnancy:
Download the HSE's new information booklet: https://goo.gl/34aLVB
Contact the Epilepsy Nurse Helpline: 01 4554133 (Monday mornings)