‘I worry about what’s going to happen when I’m gone’

Epilepsy drug in pregnancy resulted in Cavan woman’s boys having disabilities

A call by a politician for a package of measures for children left with disabilities, due to exposure in the womb to a drug used to treat epilepsy, is the sort of news story scrolled through on a news feed. It’s just a bunch of words.

The story of a mother fighting to get State support for her developmentally challenged children because she was prescribed that drug, when assured it was safe, puts an entirely different complexion on the matter.

The person in question is a 52-year-old mother of three boys who was prescribed a drug from a very early age: “I was diagnosed with petit mal at the age of 11,” she told the Celt. She did not wish to be named as she would rather her children not be identified, so the Celt will refer to her as Helen.

Epilepsy is a common, long-term brain condition. It causes seizures, which are bursts of electricity in the brain. There are different types of seizures, some more severe than others.

Generalised seizures, once called grand mal, cause a loss of consciousness and violent muscle contractions. It’s the type of seizure most people picture when they think of epilepsy. Petit mal, now called absence seizure, is a less severe form of seizure.

“I was put on the treatment Epilim. That’s sodium valproate. The only thing I was advised was to take care of my liver, not drink excessively and pay attention to my teeth and gums. There was never any mention of other side effects to the drug,” Helen tells.

Listed by the World Health Organisation (WHO) as an essential medicine, sodium valproate is an important drug in the treatment of epilepsy. Manufactured by Sanofi and marketed in Ireland under the brand name Epilim, it’s now accepted it can cause developmental disability in 30-40% of children and congenital malformation in 10% of children exposed to it in the womb.

The Cavan mother took the medication right through her first two pregnancies, her first child was born 26 years ago: “I did have queries when I was pregnant with my oldest boy. They said the benefits outweigh the risks. That was the distinctive language used. I had one seizure during that pregnancy, they actually upped the dosage of the medication...

“My son was born in what is classed ‘a normal birth’. He was induced and was 8lb 3oz. It wasn’t until he was almost three that I started to notice he was falling behind. His developmental progress just came to a halt. He didn’t talk much, he would spend his time spinning saucepan lids. At the age of three, I took him to a paediatrician and they diagnosed him as autistic. Even at that stage there was no mention of the Epilim drug.”

As Helen was fighting to get access for an assessment of her first child, she became pregnant with her second: “At that stage I was three months pregnant with my second child. After my eldest boy was diagnosed, I panicked and asked ‘what are the chances of this happening again?’. They said it was one in a thousand. That pregnancy was a troublesome one. I didn’t realise it, but I was expecting two babies.” Sadly Helen lost one of the babies.

“When my gynaecologist was on holidays, I had a haemorrhage. I went to hospital, but was sent home. They told me come back a week later to see if I needed a D&C. When I went back they found a second heartbeat, that was very shocking for me.”

Cancer diagnosis

As if all that wasn’t enough to cope with, Helen received a cancer diagnosis during her second pregnancy: “It was a roller-coaster of emotion at the time,” she recalled.

“My second son was only 6lb 2oz. There were concerns. He was blue when he was born. The hospital staff told me not to contact family members. He was rushed to an incubator, a very floppy baby. It was very difficult. Fortunately that changed and I was able to bring him home, but I realised an awful lot quicker that there were similarities to my first child.”

A mother’s instinct, coupled with the experience with her first child, put Helen on alert: “At the time there was a team that diagnosed autism in children. As I dealt with them before, I knew they were about to disband. I contacted them and got a diagnosis for my second child because I knew how hard it would be to get services without the diagnosis.

“It wasn’t until he was six that they found out he had severe learning disabilities. He didn’t speak until that age. I brought him to pre-school, he would scream instead of talk. He attended speech therapy and occupational therapy. He began to speak after the age of six. He couldn’t cope in mainstream school so he went to the Holy Family School instead. He remained there through his teens, now he’s in Rehab care.”

During the course of her children’s upbringing, Helen became aware that the drug she was taking for the treatment of her epilepsy could have been a factor in her boys’ problems: “I heard rumours about the Epilim drug. Before I became pregnant for the third time, I went to see a geneticist in Dublin... This was 14 years ago. He said there was only a five per cent chance that the Epilim drug would have had any impact on the pregnancy, he said there was a 40% chance it was genetic.”

Increased warnings

The European Medicines Agency (EMA) strengthened the warnings on valproate-based medicines in 2014 but a further review in 2017 found warnings were still not effective enough. Sodium valproate is now contraindicated in women and girls of childbearing potential, unless a pregnancy-prevention plan is in place, and may be prescribed only when other treatments are not suitable.

Helen joined a group called Organisation Anticonvulsant Syndromes Ireland. They provide support, help, and advice to other families, whose children have been affected by Foetal Anti-Convulsant Syndrome. As part of this group, she went to Crumlin Hospital last October where another geneticist undertook a barrage of tests on her two older boys. The tests confirmed that both were victims of Foetal Valporate syndrome.

“It shocked me,” she said. “He was able to tell me that there was no other reasons he could conclude that the boys had the type of disability they had other than the Epilim drug.

“I had stopped taking Epilim during my third pregnancy and my child was born perfectly normally. The geneticist compared the three boys in making his assessment. They reckon there are 12,050 children in Ireland whose mothers were given this drug from the 1980s until the late 1990s.”

Marriage broke up

The challenge of raising two boys with special needs has been particularly tough: “My marriage broke up. I’m essentially on my own to rear them.”

Along the way Helen has had support, but is concerned about the future: “My eldest was educated in The Royal School in Cavan. They were excellent. He’s now in third level college. His social skills are poor, but we are working on those. My other child is in Rehab, he will always need State support, he will probably need State care when something happens to me. That’s very difficult to deal with. I worry about what’s going to happen when I’m gone.”

Demanding supports

A Cavan Monaghan Sinn Fein TD is advocating in Dáil Éireann for mothers like ‘Helen’ and those affected by the drug valproate.

Deputy Pauline Tully said a package of measures must be delivered for families whose children were left with disabilities due to exposure in the womb to a drug used to treat epilepsy.

“A number of years ago, the affected people and families obtained a report from a genetics doctor, which was submitted to the CHO area in which they live.

“They were told a liaison officer would be appointed to engage with those concerned to identify the supports required to address their needs,” contended Deputy Tully.

Helen feels action by the HSE to give support to such affected families fall short: “It is good for families with young children. For me it’s too little, too late. When my boys were smaller I had to fight and fight to try to get services - speech therapy, occupational therapy, anything at all, was a battle. They are saying that the children will be prioritised, but I’m not sure that will do a whole lot. It is long-term plans that need to be put in place.”

An investigations into the prescribing of the drug during pregnancy has been held in France, while Britain is currently examining the issue. There have been calls for a similar investigation into the matter here in Ireland.

Helen believes many families would benefit from such an investigation: “We all have the same worries: What is going to happen when we are gone. There would have been an awareness since 1975 of this drug causing developmental delays in children. It’s only in the last few years that they put a warning on the packet telling of the dangers of taking while pregnant. People should have been warned up front. It’s a State inflicted disability, that’s very hard to swallow.”