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AN IRISH WOMAN whose children have been left with disabilities as a result of the epilepsy drug sodium valproate is to give evidence to a European safety review in London today.
Following the public hearing, the European Medicines Agency will determine whether warnings about the drug’s risks to unborn babies are strong enough.
In 2014, the EMA put measures in place across Europe to strengthen the warnings and restrictions on the use of the drug in women and girls due to the risk of malformations and developmental problems in babies exposed to valproate in the womb.
The FACS (foetal anticonvulsant syndrome) Forum Ireland, an umbrella group of patients and disability organisations, estimates that sodium valproate has affected at least 400 children with birth defects and developmental issues since it was first licensed here in 1983.
Children exposed to the drug in the womb have a 30-40% chance of serious developmental disorders and/or physical disabilities in 10% of cases.
‘They will never have a normal life’
Karen Keely, from Ireland, has three adult sons who have been affected by exposure to the drug. She’s set to speak on behalf of a number of Irish families who have also been affected.
Speaking about the effects the drug has had on her and her sons Harry, Lee and Lorcan, Keely said:
“My family is living evidence of the risks and the devastating impact of this drug.
Two of my three boys require lifelong care and will never be able to have a normal life. They will never be able to get married or have children. They have been robbed of all the joys of life.
“None of us want future generations to be affected or ignored in the same way that we have. But if we continue on the same path, that is exactly what will happen.”
Inadequate information
Today’s public hearing is in response to ongoing concerns regarding the effectiveness of the measures brought in back in 2014, and to consider whether further EU-wide action should be recommended to minimise the risks for women taking the drug.
Last week, data released by three UK epilepsy charities found that almost 70% of women taking the drug had not been given adequate information, while 20% said their healthcare professionals did not initiate a discussion about the risks.
Epilepsy Ireland conducted a number of surveys of women taking valproate and found that while doctor-patient communication is improving since 2014, just 54% of women surveyed since last December said they had discussions about the issues with their healthcare professionals.
One in five were still not aware of the new restrictions in place since 2014.
Calls for action in Ireland
Epilepsy Ireland’s CEO Peter Murphy will also be in attendance at today’s hearing on behalf of FACS Forum.
“A lot more needs to be done. Measures to reduce risk must be outcome-driven and measurable,” Murphy said.
“The use of valproate information resources should be mandatory and informed consent should be obtained when using the drug in women and girls.”
Murphy is calling for the establishment of a valproate register and a “properly resourced” public awareness campaign.
“Warnings must be displayed on the external packaging of the drug and importantly, medication should not be dispensed without original internal and external packaging,” he said.
In addition to seeking better risk reduction measures, the FACS Forum is calling on the government to identify the scale of the problem in Ireland, to assess the needs of the families affected and to put in place appropriate pathways for the diagnosis and treatment of the condition.
A toolkit has been produced by the HSE’s National Clinical Programmes for Epilepsy, Mental Health and Medicines Management, which aims to reinforce the safety message for healthcare professionals and patients.
In a statement on its website, the HSE says:
It is important that valproate therapies are not prescribed for girls or women of childbearing age unless other treatments are not effective or are not tolerated.
The appropriate information should be given to all women on valproate treatment and the checklist should be completed.
Despite the rollout of the toolkit by the HSE, Keely said more needs to be done to help families who are suffering.
“The HSE has taken some measures to improve awareness of the risks and to improve communication between patients and health professionals, these have largely been tick-box exercises with little regard for delivering real change,” she said.
“The response has been unsatisfactory and there have been no efforts made to address the needs of families already affected.”
This is the first time the EMA’s safety committee – the Pharmacovigilance Risk Assessment Committee – has held a public hearing to review the safety of a medicine.
The public hearing will be broadcast live on EMA’s website between 12.45pm and 6pm today.
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R.I.P.
When Bowies creative output started to suffer in the 80′s, Prince came in and filled that void magnificently. I always viewed Prince in similar terms to Bowie in the way they challenged the mainstream constantly with their music and image. One crumb of comfort can be taken from his premature demise and that is the thousands of unreleased material he wrote over the years and which fans can look foward to hearing in the future.
On probably his worst album ‘Never Let Me Down’, Bowie sang the line : “The Little Red Corvette has passed me by” …
‘Least greatest’ album I think is more appropriate :)
What is the obsession with celebrities when they pass away?We should be mourning scientists,Doctors,professors and not musicians.A note in a newspaper is worthy,but countless stories one after the other is not on.We are taught to worship these people now and obsess.Sad day man passess away,hey over it.it Sums up society today,willfully ignorant and brainwashed by tv and radio.
You didnt have to pay attention to the article’s on him you know, you have a choice here Lee.
Says Lee Oswald
Yes but you know I have to give my 2 cents here…if I don’t highlight the pure ignorance and lack of common sense who else will?
What’s up Elma?
Musicians of this magnitutde are mourned simply because music means so very much to people; we grow with it, it grows with us, it relieves our stress, it gives us emotional release and it has very positive influences on our energy, body and brain. Prince was a musical genius, many people are upset, obviously not you Lee but thats okay. Maybe you’ve never heard music before
The reason for this is that more people would find Purple Rain to be more emotional and uplifting than Panck’s Constant.
Says the lad called after a dead Assassin????
I think if you did a wee bit of research you would realise I was not an assassin.I had a poor shot ,I could not off pulled of the assassination due to this fact.But you believe the Warren commission,which in itself was flawed from the day it was set up.
Back and to the left, back and to the left.
I sense a slight bit of sarcasm there Elma…The fact is shots could not be done in the time scale suggested.
I’m actually with you on this one tbh.
Thank you Elma,I’m not saying I was not involved.But I certainly did not act alone.I never got the call…
Is this worthy of a separate news story?
Maybe not, but the people who own the website think so, and it’s a free world.
Using your thumbs as a guide, it would appear about 80% thinkn yes it is.
“One day of seven we’ll die”
Gotta get those clicks
Goodnight sweet Prince
RTE government and cronie buddies would not represent the independent freedom loving Prince. They might like his music but they certainly wouldn’t be down with his stances on position on certain things. Might I suggest that PrimeTime do a piece on Chemtrails a subject which Prince was vocal about ???
Maybe they could have played ” something in the water does not compute”…
I agree Mr mango…but as you can see from all the red thumbs you are gettingn most people like to be spoon Fed from the likes of rte news.They hold comfort in their Irish independent,rte news and mor ing Ireland lol.Over educated but lack independent thought and the will to question authority.
Mass media educated sheeple, fleeced of free thought, and totally oblivious to the wool being pulled down over their eyes.
Good work RTE. good work
Thats cool,Prime Time taking a leaf outta Newsnight’s book with a lighter credits and a nice music tribute. Too many rte shows are too stiff and serious
Prince, like most of us like minded, would spit on Rte and it’s lie through omission policies. Prime time is a gate keeper like the war on drugs. They proclaim to be tackling the problem when they really are helping guide the outrage which is the brainwashed masses goto first emotion in reaction to the corruption of their overlords. But even Prince’s soul can’t replace the ones Rte & it’s minions already sold to the devil.!
Surprised anyone in RTE has enough soul to appreciate Prince. Disturbing to realise I have something in common with the government droids in Donnybrook
I wonder did David McCullogh manage to stay awake to hear the tune?
They should have faded the music in rather than just blasting it straight out. It’s a nice sentiment all the same.
Pity RTE is shite for the vast majority of the time.
Last weekthe bodies of two more young males were fished out of Galway Bay and Leo the Loo Head has decided he can afford to tske €14m from mental health.There are plenty more tragedies closer to home Prime Time could theme song, maybe “Suicide is Painless”.but of course it’s not, neither is is victimless.
Prince was a fan of Dick Gregory. He had strong opinions about society and politics and would not have been a fan of state owned and government controlled propaganda tv.
And I’m sure he would appreciate you hijacking the fact they played his music to commemorate his death as an excuse to have a rant. Not.
have your say