Information on FACS

What is FACS?

FACS describes a syndrome that occurs in children born to women who were prescribed medication containing sodium valproate during pregnancy. This medication is known as Epilim in Ireland. This medication is widely prescribed for Epilepsy and Bi-Polar Disorder and other conditions such as migraine (although it is not licensed in Ireland for migraine). Children exposed to this drug while their mothers were pregnant have a 30-40% chance of serious developmental disorders and/or physical defects in 10% of cases[1] according to the European Medicines Agency (EMA).

There are a range of mental and physical disabilities and challenges associated with FACS and which can vary from one individual to another.

These have been subject to a growing list of research papers dating as far back as 1968.

These disabilities and challenges can include:

  • Distinctive facial features – (Broad flat nasal bridge, epicanthic folds, narrow forehead etc.)
  • Deformed feet (Bent, curved or crossed toes)
  • Digit abnormalities
  • Painful hips and limbs
  • Kidney malformations
  • Heart malformations
  • Spina Bifida
  • Cleft lip and /or palate
  • Hearing, vision and balance problems
  • Cognitive difficulties and learning developmental problems including autism

There may also be problems related to higher levels of neo-natal death associated with FACS.

 

European Medicines Agency  

Review of Sodium Valproate 2014:

A review of medicines containing sodium valproate undertaken by the European Medicines Agency (EMA) over a two year period recommended a significant strengthening of restrictions for their use. Product information must now reflect these new recommendations. The EMA recommended that sodium valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.

The EMA concluded that Children exposed to sodium valproate in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).

They recommended that:

  • Sodium valproate should not be prescribed to female children, female adolescents, and women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.
  • Prescribers should carefully weigh the benefits of valproate treatment against the risks when prescribing sodium valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant.
  • Sodium valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder.
  • All female patients should be informed of and understand the:
  • Risks associated with sodium valproate during pregnancy
  • Need to use effective contraception
  • Need for regular review of treatment
  • Need to rapidly consult if a woman is planning a pregnancy or becomes pregnant.

Review of valproate use in pregnancy and women of childbearing age March 2017 

The European Medicines Agency (EMA) conducted a review looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. This review was prompted by concerns about how effective the measures have been in increasing awareness and reducing valproate use appropriately The French medicines regulator, ANSM, therefore asked EMA to review the effectiveness of the measures and to consider whether further EU-wide action should be recommended to minimise the risks in women who are pregnant or of childbearing age.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) consulted with relevant stakeholder groups. FACS Forum made a submission to the committee.

They also plan to hold a public hearing about their concerns mid 2017.

 

[1] http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f.

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