If you have previously been prescribed or if you are currently taking valproate (Epilim®) and have any concerns about it, please contact your GP or your prescriber for advice and guidance. You will also find detailed questions and answers about valproate, or Epilim®, below.
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.
In February 2018, the European Medicines Agency recommended new restrictions on the use of valproate (Epilim) including a Pregnancy Prevention Programme.
Valproate (Epilim®) must no longer be used in women or girls of childbearing potential unless the terms of the Valproate Pregnancy Prevention Programme are followed. This programme includes measures to ensure female patients taking valproate (Epilim®) are fully aware of the risks and the need to avoid becoming pregnant while taking it. Valproate (Epilim®) should not be used in female children, girls and women of childbearing potential unless other treatments are ineffective or not tolerated.
It is important that women and girls who have been prescribed valproate (Epilim®) should not stop taking their medicine without consulting their doctor.
Revised valproate (Epilim®) educational materials have been developed by the HPRA and the manufacturer. They provide information on the risks of valproate and the conditions for use. You can read these documents on the HPRA website:
- Patient Guide for Women and Girls
- Patient Information Card
- Annual Risk Acknowledgment Form
- Guide for Healthcare Professionals
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 might my GP or Pharmacist be talking to me about it?
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 have been 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 have been introduced in Ireland by the Irish medicines regulator, the Health Products Regulatory Agency (HPRA).
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?
You can read a recently updated Patient Guide, Patient Card, Annual Risk Acknowledgement Form, Guide for Healthcare Professionals on the links above, or on www.hpra.ie/valproate.
GPs and specialists who have a female patient taking valproate (Epilim®) have all been asked to read this information and ensure their patients meet the conditions of the Pregnancy Prevention Programme. Women and girls who have recently had valproate (Epilim®) are asked to read the patient information and discuss with their GP and/or specialist.
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®)?
Do not stop taking valproate (Epilim®) – this is because your epilepsy or bipolar disorder may become worse. First talk urgently to your GP. This is so they can talk about your options.
- 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.
I am taking valproate (Epilim®) and I am considering pregnancy
Keep taking valproate and keep using contraception until you have talked with your specialist or GP. Read the Patient Guide. Your specialist may need to change your medicine a long time before you become pregnant – this is to make sure your condition is stable. If this is not possible, you and your specialist can discuss your options.
I am taking valproate (Epilim®) and am not planning a pregnancy
You should discuss with your specialist or GP, read the Patient Guide and use effective contraception throughout treatment. You will need to review your treatment with your specialist at least each year. During this visit you will need to read and sign a Risk Acknowledgement Form. This is to make sure you are well aware of and have understood all the risks related to the use of valproate during pregnancy and the need to avoid becoming pregnant while taking valproate.
I am going to start valproate (Epilim®); what does this mean for me?
Valproate (Epilim®) may only be started by a specialist. At this time:
If you are too young to become pregnant:
- Your doctor should only treat you with valproate (Epilim® if nothing else works.
- It is important that you and your parents/guardians know about these risks of valproate when used during pregnancy. This is so you know what to do when you are old enough to have children.
- You or your parents/guardians should contact the specialist service as soon as you start your periods to have your treatment reviewed and to discuss starting to use effective contraception.
If you are already old enough to become pregnant:
- Your doctor should only treat you with valproate if nothing else works.
- Your doctor should only treat you with valproate if you are not pregnant and you are using effective contraception.
- Your specialist will ask to perform a pregnancy test before starting valproate, and may ask you to repeat this at intervals whilst treatment continues. This is to make sure you are not pregnant.
- It is important that you always use effective contraception at all times during treatment with valproate (Epilim®).• You will need to review your treatment with your specialist regularly (at least each year).
- Your specialist will ask you to read and sign an Annual Risk Acknowledgement Form. This is to make sure you are well aware of and have understood all the risks related to the use of valproate during pregnancy and the need to avoid becoming pregnant while taking valproate.
Should I take folic acid?
Taking folic acid is generally recommended for anyone trying to have a baby as it can reduce the risk of spina bifida that exists with all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with valproate (Epilim®) use. 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?
- Your GP, pharmacist, specialist consultant or specialist nurse
- Patient organisations:
The Organisation for Anti-Convulsant Syndrome (OACS) is a patient support group for those affected by anti-convulsant syndrome.
Their Irish email address is email@example.com
- Health Products Regulatory Agency Valproate (Epilim®) page
European Medicines Agency (www.ema.europa.eu) recommendations or search “PRAC valproate”.
Version 4. November 2018