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MHRA bans valproate prescription for women without pregnancy prevention programme

24 Apr 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has today changed the licence for valproate medicines in the UK.

Sodium valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).

Sodium valproate is used to treat epilepsy. It is often also prescribed under the brand names Epilim, Epilim Chrono, Epilim Chronosphere MR, Episenta and Epival CR. Valproic acid is prescribed under the brand names Convulex and Depakote. For some people it might be the most effective epilepsy medicine.

But there is a risk of birth defects and developmental problems in babies born to mothers taking the medicine during pregnancy. Other epilepsy medicines carry some risk of these complications, but the risks with sodium valproate are higher

The changes made by the MHRA mean that healthcare professionals prescribing valproate to women or girls must make sure they are enrolled in the PPP.

As part of the PPP, the prescriber must make sure the woman or girl understands the risk if she became pregnant while taking the medicine. They must also understand the need to take contraception while on the medicine, and be referred to contraception services if needed. A risk acknowledgement form must also be completed and signed when the medicine is renewed, at least once a year.

The MHRA said that women and girls taking valproate at the moment should speak to their doctor to arrange a medicine review. The agency stressed that they should not stop taking their medicine without medical advice.

Further changes are expected to come in in the next few months. These include smaller pack sizes to encourage monthly prescriptions, and a warning image on the box. Computer alerts for GPs will also be put in place to help change the way they prescribe these medicines.

The National Institute for Health and Care Excellence (NICE) is amending its guidelines for epilepsy. Where valproate is mentioned, it will reflect the new regulations.

The European Medicines Agency (EMA) is also reviewing safety around valproate use in women of childbearing age. Stricter safety measures have been recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Medicines regulatory body CMDh backed these measures in April. The final decision will be made by the European Commission in the next few months. This will be legally binding across the EU.

Simon Wigglesworth, deputy chief executive of Epilepsy Action, said: “We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”

 

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Comments: read the 5 comments or add yours

Comments

I write as a 56 year old woman who has had epilepsy, and been prescribed sodium valproate, since the age of 11 (45 years). I am no longer of child bearing age, having gone through an early menopause and through breast cancer treatment. But I have never been advised of any risks of this drug- my son is 28 and I was never given any info of risk during my pregnancy ( 1989). I haven’t had any review of my medication for over 25 years, despite regularly being in touch with my GP. Quite simply women who are advised to stop taking sodium valproate while pregnant are “ between a rock and a hard place” - if they have a seizure whilst pregnant they also risk serious complications for the baby do they not? What steps are being taken to support ALL women who have taken this drug without being aware of the risks over many years? Are there any moves to apply for, for example, compensation, or at the least recognition that many thousands of women and their children have, at the east, been put at risk as a result of a failure to advise on this drug earlier? - I am also writing to my MP on this issue. I would appreciate your reply thank you in advance

Submitted by Sue Strickland MBE on

Hi Sue

Thanks for your message. Epilepsy treatment guidelines say you should have an epilepsy review every 12 months. If your epilepsy is well controlled the review could just be an appointment with your GP or a nurse at the GP surgery, where they ask how you’re getting on with your medicine. However if you’re still having seizures or have any concerns about your treatment you could ask to be referred to a specialist for a review.

The aim of these new measures is to make sure all women are aware of the risks of sodium valproate and take effective contraception. Women with epilepsy who want to try for a baby should be referred for pre-conception counselling. If their specialist recommends changing their epilepsy medicine, this should ideally be done in plenty of time before the woman starts trying for a baby. If a woman does get pregnant while on sodium valproate their specialist should give them advice on the safest course of action for them and their baby.

We know that unfortunately many women were not made aware of the risks of sodium valproate. We’re aware of two groups who support and campaign on behalf of women affected by this: the Organisation for Anti-Convulsant Syndrome (OACS) and Fetal Anti Convulsant Syndrome Association. 

Best wishes

Grace

Epilepsy Action Helpline Team

Submitted by rich on

Men's sperm can be affected also.

Submitted by Nicholas Fenning on

As a parent of a young adult of childbearing age who also has a learning disability and epilepsy, who is on valproate. We do not like the drug because of the issues, but it gives in the case of my teen better control than previous meds. Therefore The decision by MRHA is concerning. As far as I understand it there is a higher proportion of people in the population with epilepsy who have learning disabilities, and possibly fluctuating capacity. Thus , understanding the implications of the medication and pregnancy is likely to be difficult. What and how will medics work to to be able to ensure that such young people can make and understand appropriate decisions and risks.

Submitted by SB on

I am extremely disappointed that it has taken the UK, almost 10 years to ban this drug. The US issued a health warning, in 2009. Yet knowing the link to autism and developmental disorders, nothing in the UK was done, until 2018

Submitted by Tracey on
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