22-11-2014 | European Medicines Agency Valproate Ruling Explained

22 November 2014
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The European Medicines Agency (EMA) is an EU regulatory body, responsible for the evaluation of medicines developed being used in the EU.

Valproate is a commonly used anti-epileptic drug (AED). It is also used in the treatment of other conditions including migraine and bipolar disorder. It is also sometimes known as valproic acid, sodium valproate or valproate semisodium.

A number of recent studies found developmental problems in up to 40% of young children exposed to valproate in the womb. These problems included delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability. Previous studies had found that children exposed to valproate in the womb were at increased risk of autism, ADHD and malformations such as cleft palate at birth.

The Ruling

Because of this, the EMA has decided to strengthen warnings on the use of valproate in women and girls.

  • Firstly, doctors are now advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women; in women who can become pregnant or in girls unless other treatments have been ineffective.
  • Secondly, those for whom valproate is the only option should be advised on the use of contraception and treatment should be started and supervised by a doctor experienced in treating epilepsy/ bipolar disorder.
  • Thirdly, doctors should ensure that their patients are well informed of the risks of taking valproate during pregnancy, and should regularly review the need for treatment in female patients who can have children. Doctors should also re-assess the balance of the benefits and risks of valproate for any female patient who becomes pregnant, who plans to become pregnant and for all girls reaching puberty.

What should I do now?

  • If you are taking valproate and are pregnant, do not stop taking the medicine without consulting your doctor as doing so could cause harm to you or an unborn child. Speak to your doctor or Epilepsy Specialist Nurse as soon as possible.
  • If you are taking valproate and can become pregnant, you should use an effective method of contraception.
  • Tell your doctor at once if you become pregnant, think you might be pregnant or are planning to become pregnant. Your doctor will urgently review your treatment.
  •  If you have any questions at all about the medicine or the ruling, speak to your doctor, epilepsy specialist nurse, pharmacist or local Epilepsy Ireland office.

What happens next?

These recommendations must now be implemented in all EU countries. In Ireland, this will be the task of the Health Products Regulatory Authority (HPRA). All healthcare professionals will be notified of the new ruling and given educational materials. More information on this will be available shortly.

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