Hi everyone, I just want to share the MHRA's new guidance, which aims to make sure that women are aware of the risks to the unborn child of taking sodium valproate during pregnancy. It's been a long time coming, but it's very welcome: gov.uk/government/publicati....
The 'toolkit' described was developed with the help of a number of patient organisations, ERUK included.
All the best ERUK_RI
Ironically I was going to the doctors today to ask about this.
It's really annoying as that medication would be brilliant for me but being a 27 years old female it's just not worth the risk for me .
If anyone wants to talk about this issue, I am currently pregnant and taking sodium valproate (epilim Chrono 900mg per day).
It was a long time coming. We considered a lot of different options before we started trying, but things are going pretty well.
Happy to share my experiences and opinions of anyone wants them.
Amy
What did the doctors advise for you? I have been told that high dose of folic acid could work for me (200mg morning and night)
Do you mean you take 200mg epilim morning and night? That is a very low dose. They have not been able to prove that there is a dose below which the risks are lower, but they think that it is better if you take less than 1000mg per day. They have also not been able to prove that folic acid helps in the case of people taking valproate, but it is known to help with these kinds of birth defects in general and they recommend a higher dose (5mg per day) if you are taking valproate.
I was on 400mg morning and night and we were about to start trying for a baby but then had 2 seizures (after none for 7 years). We had lots of discussions with my neurologist and eventually decided to start trying as 800mg is quite a low dose and I was already on high dose folic acid. We tried for a few months without success and then this new report came out (some of the findings of which are in this information booklet). We were immediately scared and stopped trying and went to talk to the doctor again. He had a lot of experience treating pregnant women as he has been practicing for a long time and used to help run a joint obstetrics and neurology clinic. In his large experience he has only known of about 5 examples of these sorts of problems, which he said all occurred in women on very high doses (at least twice as much as me) or in women who did not take folic acid. Also all but one of them were minor problems such as fused fingers which could be quickly sorted with a routine operation. This put our minds at ease, and we decided to try again and became pregnant. At about 22 weeks I had a seizure and we decided (with the neurologist) to put my dose up to 900mg per day, which is only a tiny increase, but now I have about 1 1/2 times as much blood as I did pre-pregnancy, so the dose in my body is actually going to be a lot more diluted! Also the neural tube defects occur in the very early stages of pregnancy, so hopefully a higher dose now will not effect baby. I've not had any more seizures since.
The important thing is that you know about the risks, but you also know that there are risks in every pregnancy and in fact they are actually not increased many times in women taking sodium valproate. Of course I will feel upset and guilty if my baby has a problem (by the way I am now 28 weeks and there are no obvious physical problems from the scans I have had so far). However, it could be that my baby would have had problems anyway. I will never know.
This has been a very difficult journey for me and my husband so far, but our families and my neurologist have been very supportive. He made it clear that he could only advise, but he was much happier for me to get pregnant on a low dose than come off it to get pregnant. My history suggests I would have a lot of seizures in that case which would be very dangerous for myself and the baby.
All the best of luck. I hope you make the decision that is right for you. Xx
And I should also say there is not really any hope of any other anti epileptic drugs working for me. I tried lamotrigine and keppra prior to epilim and neither worked at all. My neurologist thinks this also means that most or all other options wouldn't work either. Epilim has changed my life and made it almost normal. Such as shame about these side effects...
Hiya i would just like to know how ur little 1 is now?? As im trying for a baby but they want to take me off this medication but im scared to..but im gonna see if i can a little dose of it but scared if.it will effect my baby thank you xxx
Hi Jodie,
My little boy is 15 months old now and he's amazing! There doesn't appear to be anything at all wrong with him so far. Of course there are some things in the list that epilim can increase the risk of which might not be spotted this early, for example, autism.
We're currently going through the same discussions again with neurologists about what to do he woth my medication as I'd like to try for another baby within the next 12 months. Because I had another seizure at 33 weeks and a couple after Jack was born I'm now back on a high dose of epilim (1600mg). I could reduce it again but I'm also considering trying carbamazepine which might not control my absence seizures but is good at controlling tonic clonics.
It's tough. Even though it appears to have worked out once doesn't mean it would again...
Best of luck with whatever you decide. Xx
Oh dear... I am not very happy with this. I feel that the risks they have published are quite misleading.
The "10 in 100" risk of being born with a birth defect (which is only around 4 times more likely than to people not on SV by the way) lists that this may include ... , where ... is all the worst possible examples. It doesn't mention that this also includes incredibly minor birth defects, which are much more common, such as fused fingers or toes, which can be sorted out quickly and without much fuss. There should be separate values given for major and minor issues!!! As a statistician I find this very, very bad practice!!!
There is also no mention that this is likely to be related to the dose of SV that is being taken, hence why I am on a much lower dose now than I am comfortable being on to ensure no seizures at all.
I don't think it mentions either how dangerous it is to regularly have seizures while pregnant.
Although they mention folic acid, they need to put more of an emphasis on it (and taking it at a high dose from as soon as you consider becoming pregnant). Although it hasn't been proven to help in the case of people taking SV, it is also not certain that it doesn't help and it DOES help with birth defects in general!
Reading it actually made me feel guilty about getting pregnant even though I have been over these issues (and these numbers) many times with my neurologist and my husband.
Although it is really important that people get the facts, I am not sure that all the facts are in here. I feel like this has been published with the express desire to put women taking SV off having children, rather than helping them make a balanced decision.
Very upsetting.
Hi Amy, first of all many congratulations, I wish you all the very best.
We are aware of your points, and raised them with the MHRA; but the discussions that took place involved lot of patient groups, and included women whose children are very severely affected. They were not informed of the risks beforehand, even though these were known, and they understandably hold a lot of anger. Their voice was very prominent, and often emotional; and what you see is a very toned down version of what a lot of them wanted.
There are indeed risks associated with having seizures during pregnancy, but they haven't been properly quantified as yet unfortunately.
We have also encountered different statistics to those reported, but we were told that these figures weren't robust enough to be used in this initiative.
The aim of this is for every woman to be fully informed of the risks before having a child whilst taking valproate, as this is not happening. The aim is not to make people who do go ahead feel guilty, but I am very sorry to hear that it is coming across this way.
Mike Dykes at the MHRA is leading on this - I will private message you his email address in case you want to drop him a line.
All the best,
ERUK_RI
Shame this wasn't out 20 years ago they make me so angry, they knew the effects this could have saved a lot of babies being born with serious defects
I'm so glad that everyone can see the dangers of this drug and the birth side affects, I was told my baby was a Down syndrome baby before she was born and that I should abort her I was given no other reason but that, at the time I was on epilim now I have found out that She should of had test done for something called mosaic downsyndrome where a child has some features of a downs baby . If I had known all this would I of got rid of her no but I would of changed my medication sooner that's for sure, I was a zombie on epilim never again. 😔
Hi,
My wife is taking Sodium valproate 500 mg per day. And we are planning for family. So the does which she is taking can also have birth defect or any form of disability and what preventive measure we should take for health child
