Toolkit on the risks of valproate medicines in female patients

Information about the toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

14107630_10154526274844359_3141616800511632754_o

Sodium Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened.

INFACT has worked with industry, healthcare professionals and patient groups on a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

In women who take valproate while pregnant, around 1 in 10 babies will have a birth defect.

Birth defects seen when mothers take valproate during pregnancy include:

Spina Bifida (where the bones of the spine do not develop properly)
facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
malformations of the limbs, heart, kidney, urinary tract and sexual organs.
In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.

The effects on development can include:

being late in learning to walk and talk
lower intelligence than other children of the same age
poor speech and language skills
memory problems.
Children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders. There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).

Current advice
Valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. Women of childbearing potential must use effective contraception during treatment.

No-one should stop taking valproate without discussing it first with their doctor and the benefits of valproate treatment must be carefully balanced against the risks.

If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.

Patient Guide (Please click to view)
http://www.medicines.org.uk/emc/RMM.421.pdf

Sodium Valproate Guidelines

Sodium Valproate Guidelines

EPILIM

EPILIM

New warnings and guidance on prescribing sodium valproate to girls and women with epilepsy have been issued by the MHRA (Medicines and Healthcare Products Regulatory Agency).
Research has shown that sodium valproate can cause serious problems in a developing baby. Of babies whose mothers take sodium valproate during pregnancy, up to 1 in 10 (10%) are at risk of having a birth defect, and up to 4 in 10 children (up to 40%) have problems with development and learning as they grow.

Therefore sodium valproate should not be prescribed to girls or women who are pregnant, or who may become pregnant in the future, unless other anti-epileptic drugs (AEDs) do not work to control seizures, or they cause unbearable side effects.

There are various different forms of sodium valproate available, including Epilim, Episenta and Epival. It may also be called ‘valproate’ or ‘valproic acid’.

Pregnant-woman-1024x680

Effective contraception

Women and girls taking sodium valproate need to use an effective method of contraception to avoid an unplanned pregnancy. As some anti-epileptic drugs can affect how well some contraceptive methods work, it is important to use the most effective methods for your situation, and ask your specialist or family planning advisor for advice if necessary.

Planning a baby or already pregnant?

Women and girls with epilepsy need to talk to their specialist about their drug treatment:

before they become pregnant and before they stop taking their contraception, or
as soon as possible if they are already pregnant.
This preconception counselling is essential when taking any anti-epileptic drugs, but especially so for sodium valproate.

If you are taking sodium valproate

Do not stop taking sodium valproate, or any other AEDs, unless your specialist has advised you to, but talk to your specialist as soon as possible about the best options for you.

If you suddenly stop taking your AEDs, it could cause your seizures to increase, or to become more severe. Seizures could cause more harm for you and your unborn baby than any risks associated with the drugs themselves.

It is important to recognise that sodium valproate is an effective treatment for epilepsy, and that for some girls and women, it might be the only drug that controls their seizures. However, for others there may be alternative AEDs that can be used.

How sodium valproate can affect a developing baby

Birth defects

6095_1172148857913_4866200_n

When sodium valproate is taken during pregnancy, it can affect how the baby develops in the womb and cause ‘birth defects’, including:

‘minor malformations’ (such as small fingers and toes) and
‘major malformations’ (such as spina bifida or a cleft palate, which may need surgery to correct them)
These risks may apply to other AEDs but appear to be higher for sodium valproate than for other AEDs.

Development and learning problems

When sodium valproate is taken during pregnancy, it may also affect the child’s development and learning after they are born and as they grow up (sometimes known as ‘fetal anti-convulsant syndrome’). These problems can include:

delayed walking and talking
poor speech and language skills
memory problems
lower intelligence than other children of the same age
Premature Birth
Small fingernail
Spina Bifida / Cerebral Palsy
Limb defects
Joint Laxity
Characteristical facial features
Delay in reaching milestones
Gross and fine motor skills
Autistic Spectrum Disorders
Speech and Language Delay
Attention and memory difficulty
Vision problems
Incontinence
Inguinal Hernia
Hypospadias
Children exposed to sodium valproate in the womb are also more likely to have an autism spectrum disorder.

All the above risks appear to be higher for sodium valproate than for other AEDs.

https://www.gov.uk/drug-safety-update/valproate-and-of-risk-of-abnormal-pregnancy-outcomes-new-communication-materials