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Inadequate warnings given for risks of epilepsy medication in pregnancy?

View profile for Carla Duprey
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Inadequate warnings given for risks of epilepsy medication in pregnancy?

The European Medicines Agency (EMA) is currently reviewing whether patients were given adequate warnings regarding the use of the epilepsy drug, Sodium Valporate, during pregnancy. This review includes a Public Hearing where evidence is being given by families who have been affected, experts and the Manufacturer of the drug.

Sodium Valporate is a commonly prescribed anti-epileptic drug, and it is often known as the brand names Epilim, Episenta or Epival. It is a very effective treatment, but it has been found that it can cause damage to fetuses within the first few days of conception and it was previously recommended that further information should be given to women who were taking the medication.

The risks of taking the medication include a 10% risk of a baby being born with physical abnormalities (such as spina bifida) and a 40% risk of a baby having delays in their development and learning difficulties.

It appears that the risks of taking Sodium Valporate during pregnancy may have first come to light in the 1970s but, although health professionals were made aware of the potential dangers, the patient information leaflets were not updated.

Subsequently, in 2016, the Medicine & Healthcare Products Regulatory Agency (MHRA) provided new guidance to both health professionals and patients regarding the use of Sodium Valporate. It was recommended that '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' and that doctors made sure that '...all female patients are informed of and understand: the risks associated with valproate during pregnancy...'.

However, recent research by epilepsy charities has found that one in six women who take Sodium Valporate are still unaware of the dangers of taking the medication for their unborn children.

It is hoped that the Hearing will highlight the issues with Sodium Valporate and the EMA will be providing a report on their findings by end of the year. Campaigners are also urging the Health Secretary, Jeremy Hunt, to make a public warning about the drug to try and ensure all women are aware of the implications of taking it and to make it mandatory for them to have regular review appointments with their doctors.

Taking any type of medication during pregnancy brings up a lot of issues and mothers must be told the risks and benefits involved, so that they can make an informed choice both for themselves and their child. In the past, there was the tradition of 'doctor knows best', but nowadays the law is very clear that patients are entitled to know about the medication/treatment that is being recommended and be given information that is relevant to them to allow them to make their own choices.

If you believe that you have not been given all of the necessary information to make an informed decision about your medical treatment, then then we have a dedicated team of clinical negligence solicitors who would be happy to advise you further.