Sodium Valproate has been part of my life for as long as I have had epilepsy, it was the first drug I was put on as a child and it worked for me and was again reintroduced to me at 21. So it has been a strange few weeks seeing it all over the news and I feel like it is time I spoke up. Today (Tuesday 26th September 2017) the European Medicines Agency (EMA) held a public hearing as part of its safety review on the use of valproate-containing medicines in women who are pregnant or of childbearing age. This is the first time a public hearing has been held during an EMA safety review.
In 2014, the EMA recommended measures to strengthen warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. Some EU member states have since carried out additional assessments of the impact of the measures at national level and concerns have been raised about how effective the measures have been in increasing awareness and reducing valproate use appropriately in its various indications. The French medicines regulator, ANSM, requested the EMA review the effectiveness of the measures and consider whether further EU-wide action is warranted.
So lets start with the horrid truth, all Anti epileptic drugs (AEDs) comes with risk in pregnancy, for some of the meds the risk isn’t fully known, for others it is known and that information hasn’t reached patients. 70% of women of child baring age who were questioned by Young Epilepsy, Epilepsy Action and Epilepsy Society said they had not received the safety warnings about Sodium Valproate. Sodium Valproate comes with a 10% risk of birth defect and a 40% chance of learning and development problems. They are scary figures and women deserve the right to know, however the information has not been reaching women and even with all the new tool kits and warnings this information still isn’t reaching women, and that is WRONG on so many levels and my aim will always be to ensure that women receive all the information to make informed decisions. However I wanted to balance the argument, and please know whilst I am writing this that I am not dismissing or underestimating the harm this drug does or the fact women haven’t been made aware of this.
As I said I was 7 when my relationship with Sodium Valproate began, a frightened child these huge purple pills became my saviour, they stopped my seizures and several years later I was weaned off Valproate. When my seizures returned at 21 it was the natural choice for me to go back onto Valproate; it was the medication that allowed me to finish my degree and to travel the world and for that I will always be thankful. At 23 my epilepsy nurse identified myself and Chris were in a serious relationship and approached me about coming off Valproate because of the risk to any unborn babies. I laughed telling her that I had no plans to have a baby and very straight faced she told me “accidents happen” so she took me off Valproate and introduced Lamotrigine. She was ahead of her times and the choice she made for me then was probably one of the best anyone has ever made for me, it meant that worrying about Valproate when pregnant all these years later wasn’t a problem for me. I struggle with the choices I made to continue my AEDs and introduce others, so I am eternally grateful that this wonderful woman had the foresight to make sure worrying about the effects of Valproate wasn’t one of them. What she also highlighted, and it is worth noting now, is that all the medications come with a risk so it isn’t a straight forward case of coming off Valproate which is a risk to a drug that poses no risk.
What concerns me is whilst the risks of Valproate are being highlighted (rightly so) it worries me that it will turn women away from the drug, and means women will suddenly stop taking a drug which works for them during pregnancy or even before. The thing is Sodium Valproate WORKS! For some people it is the ONLY thing that works, Tonic Clonic seizures that are uncontrolled are an unacceptable option for anybody especially when this would put patients at risk of Sudden Unexplained Death in Epilepsy (SUDEP). In recent weeks I have heard calls for Valproate to be banned totally but we must not lose sight of the bigger picture – pregnant women are only a small portion of those who take Valproate, are we really talking about punishing the thousands? The key to this is information, ALL the risks explained so women can make INFORMED choices.
The flip side to that is in recent months I have seen women turn away from support groups because they have been attacked for making the CHOICE to continue Valproate whilst trying for a family, this is after having all the risks explained. They came to the decision that the risks of Valproate were out weighed by the risk of seizures, and still I have seen women torn into, that’s not what we want, women should have the freedom to make the choice.
People I have connected with via my blog who in recent days have told me, “this drug is the reason I am here” “this drug is the reason my wife and child are here safely” “This drug is the only one that works for me”. YES Valproate can cause harm but we can’t ignore the thousands that it helps, we can’t start a campaign that is going to scare women into stopping taking a drug and potentially put their lives at risk. We can’t ignore those who live a ‘normal’ life because of this drug, those who have driving licence and those who have been seizure free for years and just whip away their lifeline.
What has happened to these children because of the negligence of medical professionals is dreadful and we must ensure it doesn’t happen again, but that must not come at the detriment of thousands of others who take Sodium Valproate. It is also time somebody acknowledged that it is the drug that has done this to these babies, took responsibility and stood up and offered the families of those affected help. We can’t change what has happened to those babies but we can support their families going forward.
The point was raised at the EMA Hearing that Valproate should not be discarded for every young woman with epilepsy. Kim Morley (the only Epilepsy Midwife specialist in the country) told of one of her patients who when referred to her was on four AEDs and being home schooled due to clusters of seizures, she was never offered Valproate. Then she was told of the risks and she was weaned off the FOUR AEDs and onto Valproate; she returned to school, went to college and is now at University. This is a woman who put simply wanted to achieve her dreams before she even considers children and until she met Kim was being denied that chance. It’s a prime example of the medical profession not using the knowledge in a consistent way, some women aren’t being warned of the risks, whilst Valproate isn’t even being suggested to others when it may be the most appropriate drug at the time.
Another point that came up at the EMA Hearing is that there is no consistency in presenting the ratio of risk across Europe or even in the UK alone. It was discussed the importance of the role pharmacists play, that they are vital in getting the message across to women, but ultimately health care professionals need to start working together to make the message loud and clear.
I hope that the EMA hearing and out comes brings answers and support to the families affected, that it raises awareness of Fetal Anticonvulsant Syndrome and also leads to more research into ALL epilepsy medications in pregnancy. Put simply Health Care Professionals need to start working together to ensure women are given ALL the information available and then are able to make an INFORMED choice about medication in pregnancy.
Given Women the CHOICE then give them a VOICE.
Guidelines on Sodium Valproate: http://www.theabn.org/resources/abn/e/abn-statement-on-valproate-g.html
EMA Hearing: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f
Sodium Valproate Toolkit survey: https://www.epilepsy.org.uk/news/news/almost-one-fifth-women-taking-sodium-valproate-epilepsy-still-not-aware-risks-pregnancy
NEW Facebook page: https://www.facebook.com/fairyfaye1986/?ref=aymt_homepage_panel
Facebook support group: https://www.facebook.com/groups/739520702798749/
My names Faye, mostly known for being a tea addict and keen runner and swimmer. I'm 32, married and I had my 1st child in June 2015, oh and I also happen to have epilepsy. This is my story of Pregnancy, Motherhood & Epilepsy.