In February 2018, the European Medicines Agency recommended new restrictions on the use of valproate (Epilim) including a Pregnancy Prevention Programme.

Treatment with valproate must be initiated and supervised by a specialist experienced in the management of epilepsy or affective disorder.

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.

Women of child-bearing potential who have to take Valproate are required to be reviewed by the specialist prescribing the medication on an annual basis and an Annual Risk Assessment Form (ARAF) has to be completed at the time of the review.

Valproate

Valproate is a medicine licensed in Ireland to treat epilepsy and affective disorder. It is known as Epilim® in Ireland and other brand names exist in other countries. If a woman or girl becomes pregnant while taking valproate (Epilim®), their baby is at risk of serious birth defects and developmental and learning disorders.

It is important that women and girls who have been prescribed valproate (Epilim®) should not stop taking their medicine without consulting their doctor.

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.

For further information on Valproate please also see the HPRA (Health Products Regulatory Agency) website Valproate (Epilim-).

There are also patient information leaflets provided by the HPRA available for further information. Please see the link to the leaflets in the subsection at the side for further information.

Effect of Valproate on unborn children in the womb:

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 and/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).

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 have attention deficit hyperactivity disorder (ADHD).

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

Do not stop taking valproate (Epilim®) – this is because your epilepsy or affective disorder may become worse. Immediately contact your GP and the specialist who is prescribing your Valproate.

•  If you have epilepsy, you or your doctor should request an urgent appointment with the specialist.
• Contact the Epilepsy Clinic that you usually attend, or your nearest clinic, and speak with a specialist nurse or specialist consultant to let them know you are pregnant.
•  If you have affective disorder, you or your doctor should request an urgent appointment with the specialist.
• Contact the psychiatrist or clinic that you usually attend, or your nearest clinic, and speak with a specialist nurse or specialist consultant to let them know you are pregnant.
•  If you have another condition for which you are taking Valproate, you need an urgent appointment with your GP or your specialist to let them know you are pregnant.

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 contraception options 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 once a year.

During this visit you will need to read and sign the Annual Risk Acknowledgement Form. This is to make sure you are 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.