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A European wide safety review has been held in London this week to hear evidence from women whose children have suffered following the use of a common epilepsy drug. The drug in question, Sodium valproate, is linked to an increased risk of birth defects and developmental problems in babies born to mothers taking the medicine.

According to the BBC, babies whose mother took the drug during pregnancy have a one in ten change of developing physical abnormalities and a four in ten chance of developing behavioural problems.

Sodium valproate is used to treat all types of epilepsy in adults and children. It is an anti-epileptic drug also known as anti-convulsant. It is used to calm electrical activity in the brain of patients with epilepsy. The drug can also be used in the treatment of manic episodes in bipolar disorder. For some people with epilepsy, it is a very effective medicine to control seizures and, in some cases, may be the only medicine that treats their symptoms.

In a survey conducted by Epilepsy Action, almost one fifth of women taking the epilepsy medicine were unaware of the risks the medicine can pose during pregnancy. Some of the women whose children were affected state that no one warned them of the extent of the dangers to their unborn children.

Fetal Valproate Syndrome can occur when the foetus is exposed to Sodium valproate and effected children can suffer from the following: 

  • haracteristic facial features;
  • developmental delay;
  • motor control difficulties;
  • difficulty paying attention;
  • memory problems;
  • lower IQ;
  • speech and language problems;
  • difficulties with vision;
  • poor muscle tone;
  • autistic spectrum disorders;
  • hernia in the groin;
  • Hypospadia (only in boys)
  • limb and heart defects and;
  • Spina Bifida.

Charities are now calling on the Government to change the way repeat prescriptions of sodium valproate are made for women of childbearing age. They are asking that repeat prescriptions are not routinely renewed for more than 12 months without a face to face consultation with a doctor or nurse. This consultation must include specific information about the dangers of taking sodium valproate during pregnancy, and should also be provided in writing. 

In France, it is estimated that up to 4,100 children have suffered from severe malformations since the drug was introduced in the country in 1967. The families are looking to sue the drug manufacturer, Sanofi, with the support of the French Government.

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