Mum-of-seven told 'nothing' about sodium valproate risks which 'damaged health of children'
Report by ITV Wales Correspondent Richard Morgan
Every day, Pam Dumayne from Abergavenny takes a drug which probably keeps her alive.
But it's also caused her untold heartache.
She took the anti-epilepsy medication Sodium valproate - or Epilim, to use its brand name - throughout her seven pregnancies.
But all seven children had health problems, ranging from heart murmurs to learning and psychological difficulties.
Two daughters, Jessica and Hannah, died in childhood because of, Pam says, complications brought on by the drug.
While her youngest son, 27-year-old Josh, has a learning disability and will never be able to leave home. She says she wasn’t told anything about the potential risks posed by the medication during any of her pregnancies.
Pam explained: "Nothing. I even asked ‘Is it a possibility that the medication can hurt the unborn baby?’ They said no. And even when the children were getting older and started having learning disabilities and physical disabilities we questioned it again, and the answer was 'no.'"
"I still feel guilt now."
What is Sodium valproate?
Sodium valproate is used to treat epilepsy, bipolar disorder and occasionally migraine headaches.
This medicine is only available on prescription as capsules, tablets or a liquid, and can also be given by injection in the hospital.
Among women who take valproate during pregnancy, around 10 in every 100 babies are born with birth defects, compared to two to three out of 100 of the general population.
Examples include spina bifida, facial and skull malformations include cleft lip and palate, as well as malformations of the limbs, heart, kidney, urinary tract and sexual organs.
The medicine can also lead to long-term learning difficulties and development problems, affecting between 30 to 40 babies in every 100. These can include walking and talking later than other children of the same age, poor speech and language skills, memory problems and lower intelligence than other children of the same age.
Furthermore, children whose mothers took valproate while pregnant are more likely to have autism or an autism spectrum disorder. These children are also more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
Although Pam believes all her children have been affected, only one, Josh, has been officially diagnosed with foetal valproate spectrum disorder.
He works, but is having to accept that he’ll have to miss out on many of the things that others take for granted.
"Marriage, having your own house, doing what everyday people do. That was taken away”, says Pam.
“Socially, he’s restricted in a lot of things he can do.”
In 2018, the Medicines and Healthcare Regulatory Authority (MHRA) introduced a "pregnancy prevention programme" for women of child-bearing age who take sodium valproate.
Rules include requiring healthcare professionals to review medication with patients each year and to ensure they're on effective contraception.
There’s also a statutory requirement for health warnings to be printed on packaging and in information leaflets.
In spite of these measures, it’s thought up to 200 unborn babies a year are still being exposed to valproate.
Janet Williams and Emma Murphy, of the campaign group the Independent Foetal Anti-Convulsive Trust (INFACT) say 20 thousand children been affected since 1973.
They’re leading calls for compensation to be offered to families that have suffered.
“[The authorities] should be clamping down on this but they’re still dragging their heals.”
“It’s truly horrific that it’s been allowed to continue.”
"We've had one example of a lady who got caught pregnant and the doctor just turned round and told her to have an abortion. That is truly horrific and scandalous", Emma explained.
Janet added: “We never ever wanted the drug banned, and we still don’t want that.”
“It’s up to MRHA to make sure that this Pregnancy Prevention Programme they’ve got in place actually works.”
“There are other medications out there with Pregnancy Prevention Programmes tat do work. So why isn’t this?”
In response, a Department for Health and Social Care spokesperson said: “Our sympathies remain with all those affected by the side effects of sodium valproate – patient safety is a priority and we are committed to improving how the system listens to people.
“We are seeking views from the Patient Safety Commissioner regarding redress in England. As an interim measure, NHS Resolution has published a claims process for those affected by pelvic mesh and sodium valproate.”
A Welsh Government spokesperson said: “We are keeping the potential for a redress scheme under review. We continue to work to improve the safe use of valproate and reducing the number of children affected by exposure to valproate during pregnancy.
“The use of valproate amongst women and girls of childbearing age has decreased significantly in Wales and we have established an expert group to advise on how to reduce exposure even further.”
The use of valproate amongst women and girls of childbearing age has decreased significantly in Wales and we have established an expert group to advise on how to reduce exposure even further.”
Meanwhile, Pam says compensation is a priority so she and other families can plan for the future.
"That money would secure Joshua's future. And there are children who are more disabled than Joshua, much more disabled. And that money is crucial to the children’s' future."
Recently, UK Government health minister Maria Caulfield said she was “willing to look at the idea” of a redress scheme.
Adding that the Patient Safety Commissioner - who was described as “sympathetic” - had been asked to look into the matter.
Thus far, through, families like the Dumaynes haven't received a penny of compensation.
It’s hoped that will change in time for their children to benefit.
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