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22 January 2015

Doctors in new warning about epilepsy drug valproate

Results of a Europe-wide review of the epilepsy drug valproate, known to cause birth defects, has resulted in the Government sending strengthened warnings to all prescribing doctors and pharmacists.

Epilepsy Society has welcomed the move by The Medicines and Healthcare Products Regulatory Agency (MHRA) to alert health care professionals to the risks of prescribing the drug, also known  as sodium valproate, valproic acid, Epilim, valproate semi sodium and Depakote, to women of child bearing age.

The review found that children exposed to 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).

The MHRA says 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.  It also states that treatment with valproate must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder.

Balance the benefits and risks

Healthcare professionals must carefully balance the benefits of valproate treatment against the risks when prescribing 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.

Doctors must also ensure that all female patients are informed of and understand the risks associated with valproate during pregnancy

  • the need to use effective contraception
  • the need for regular review of treatment
  • the need to rapidly consult if she is planning a pregnancy or becomes pregnant​ 

Seek expert advice

Professor Ley Sander, Epilepsy Society's medical director, said: 'Women taking the anti-epileptic drug sodium valproate must not panic and must not stop taking their medication in the light of this news. They should seek advice from an epilepsy specialist as soon as possible and together they should consider the options. Women who are considering becoming pregnant should also discuss their treatment options in advance of becoming pregnant.'

Read the Department of Health's patient information booklet about the risks associated with valproate in female children, female adolescents, women of childbearing potential and pregnant women.