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Warning over links between sodium valproate and birth defects

1 October, 2003

The Committee on Safety of Medicines, the UK government body responsible for ensuring the safety of medication, has issued a warning about women of child-bearing age taking the anti-epileptic drug sodium valproate.

Figures from the UK Epilepsy and Pregnancy Register, issued in October 2002, showed that the risk of birth defects in children born to women taking sodium valproate was two to three times that of women taking other anti-epileptic drugs such as carbamazepine or lamotrigine.

The Committee has advised that:

  • Women of childbearing age should not be prescribed sodium valproate without specialist neurological advice
  • Women taking sodium valproate who are likely to become pregnant should receive specialist advice
  • If taken during pregnancy sodium valproate should be prescribed as monotherapy at the lowest effective dose
  • Folic acid supplements prior to pregnancy may reduce the likelihood of birth defects in infants born to women at high risk

A spokesman for the charity Epilepsy Action welcomed the action taken by the Committee:

"In our ongoing women's campaign, we have strongly encouraged women with epilepsy planning a pregnancy to seek pre-conception counselling, including a clear and understandable explanation of their anti-epileptic drug option during their pregnancy. Women with epilepsy shouldn't take sodium valproate without specialist advice and those already taking the drug should not stop without talking to their doctor first.

"While we realise that for some women sodium valproate is the most appropriate drug to control their condition, we do believe they should all be assessed by a specialist and their medication reviewed. It is important that women are able to make informed choices."