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Valproate

Valproate (Epilim) Toolkit

Valproate is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. It is known as Epilim® in Ireland and other brand names exist in other countries.

If a woman becomes pregnant while taking valproate (Epilim®), their baby is at risk of serious birth defects and developmental disorders. The EMA, the European medicines regulator, has recently recommended new restrictions so that women on this medicine are made aware by their healthcare team of the risks to their baby of taking this medicine while pregnant.

The HSE has prepared a Question and Answers page for patients, which you can read below.  The Valproate toolkit below contains a patient information leaflet, and resources for health professionals.  This information was produced by the National Clinical Programmes for Epilepsy, Mental Health and Medicines Management in consultation with the HPRA and patient groups and aims to reinforce the safety message for healthcare professionals and patients.

See below for the online toolkit. 

The European Medicines Agency updated their recommendations on valproate in February 2018. As a result of this, our information and documents will be updated during March 2018, so please check back often or look for updates at your GP surgery.

Valproate Patient Information Booklet.pdf (size 1.3 MB)

Valproate Guidelines.pdf (size 136.1 KB)

Valproate Checklist.pdf (size 69.4 KB)

Valproate (Epilim®) Questions and Answers for Patients

What is valproate (Epilim®)?

Valproate is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. It is known as Epilim® in Ireland and other brand names exist in other countries.

Why is my GP talking to me about it and why is it in the news?

If you take valproate (Epilim®) while you are pregnant, it can seriously harm your unborn child. This can happen in two ways- it can cause birth defects or problems with development and learning.  Restrictions are being introduced to make sure that women and girls are aware of the risks and can take care to avoid getting pregnant while taking this medicine. These restrictions are being introduced throughout Europe by the European medicines regulator, the European Medicines Agency (EMA).

What are the risks?

If you take valproate (Epilim®) when you are pregnant it can seriously harm your unborn child.
1 in 10 babies may have a malformation of their body at birth
3 or 4 in every 10 children may have serious developmental disorders
Risk of childhood autism is 5 times more likely compared with the rest of the population
Children are more likely to develop attention deficit hyperactivity disorder (ADHD)

What information is available?

A HSE patient information booklet, healthcare professional guide and checklist for prescribers and patients are available on www.hse.ie/valproate. GPs and specialists who have a female patient taking valproate (Epilim®) are being asked to read this information and draw their patient’s attention to it.
Following a European recommendation in February 2018, updated information will be circulated to healthcare professionals by the Health Products Regulatory Authority (HPRA), the Irish medicines regulator. GPs and healthcare professionals will update their procedures on this medicine as soon as this guidance is completed and shared.

Who is at risk?

Women and girls taking valproate (Epilim®) who are able to become pregnant are at risk, especially if they are not using effective contraception. Men taking valproate, or women who are not able to become pregnant, are not at risk.

What if I am pregnant and I am taking valproate (Epilim®)?

If you are pregnant and taking valproate (Epilim®), you will need an urgent review at your specialist clinic.
If you have epilepsy, you or your doctor should request an urgent review at the next specialist clinic. Contact the Epilepsy Clinic that you usually attend, or your nearest clinic, and speak with a specialist nurse or specialist consultant.
If you have bipolar disorder, you or your doctor should request an urgent review at the next specialist clinic. Contact the psychiatrist or clinic that you usually attend, or your nearest clinic, and speak with a specialist nurse or specialist consultant.
If you have another condition, you need an urgent review with your GP or your specialist clinic.
Do not stop taking valproate (Epilim®) without speaking to your doctor/specialist nurse - this is because your epilepsy or bipolar disorder may become worse.

I am taking valproate (Epilim®) and am considering pregnancy

You should consider your options with your specialist or GP and read the patient information booklet on www.hse.ie/valproate. In most cases, your treatment may be changed. If this is not possible, you and your specialist can discuss your options.

I am taking valproate (Epilim®), I am of child-bearing age but not planning a pregnancy

You should discuss with your specialist or GP, read the patient information booklet on www.hse.ie/valproate and use effective contraception throughout treatment.

I am going to start valproate (Epilim®) and I am able to have children; what do I need to do?

Valproate (Epilim®) may only be started by a specialist. At this time:
The specialist must assess with you your chances of getting pregnant, and discuss with you the risks involved, and how to prevent pregnancy
You must have a negative pregnancy test before starting treatment
You must receive counselling about the risks of valproate (Epilim®) treatment
You must agree to use effective contraception throughout treatment.

Should I take folic acid?

All women should take folic acid prior to and during pregnancy to protect against a type of birth defect called neural tube defects. Women who are taking valproate (Epilim®) may be advised to take a higher dose of folic acid (5mg per day) than women who are not taking valproate.
However, folic acid does not reduce the risk of most of the birth defects that may be caused by valproate (Epilim®). This is why pregnancy prevention is recommended throughout treatment with valproate (Epilim®).

I was taking valproate (Epilim®) when I was pregnant and I am concerned that my child was affected by valproate (Epilim®). What should I do?

Talk with your GP first. Your GP may refer your child for review by a paediatrician, or by another specialist if they are an adult.

Where can I go for more information?

Clinical Strategy and Programmes Division