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Ban on epilepsy drug, sodium valproate in pregnancy

Towards the end of 2017, families harmed by the epilepsy drug sodium valproate demanded a public inquiry and compensation, following a public hearing in London.

At the time, guidance advised women of child-bearing age to only take sodium valproate as a last resort.

On the 24th April 2018, drug regulator the MRHA says the drug must no longer be prescribed to girls and women of child-bearing age in the UK unless they sign a form to say that they understand the risks.

The MHRA says the new measures will keep future generations safe and are being supported across the NHS with other authorities also making changes – such as new GO system computer alerts, to make sure changes in prescribing behaviour take place promptly.

The MHRA has changed the licence for valproate so any doctor prescribing it will have to ensure female patients are put on a Pregnancy Prevention Programme, which means:

  • The patient can see her doctor every year to discuss the risks of this drug to an unborn baby
  • She signs an acknowledgement form at least every year
  • She is told about the importance of using contraception throughout treatment and having a pregnancy test if she thinks she could be pregnant

Valproate is a treatment for epilepsy and bipolar disorders, with children born to women who take valproate during pregnancy at a significant risk of birth defects and persistent developmental disorders. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects. Dr June Raine, director of MHRA’s Vigilance and Risk Management of Medicines Division said:

Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.

Let us take it from here.

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