<< back

MHRA changes licensing for valproate prescriptions to female patients

Epilepsy drug valproate must no longer be prescribed to girls and women of childbearing age in the UK unless they are on a pregnancy prevention programme, writes Faye Marks of the Clinical Negligence team

In April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for regulating all medicines in the UK by ensuring they work and are acceptably safe,  changed the licensing for valproate, a drug used to treat epilepsy and bipolar disorder.  Valproate is marketed under the brand names Depakote and Epilim, among others.

Risks of valproate prescriptions

In April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for regulating all medicines in the UK by ensuring they work and are acceptably safe,  changed the licensing for valproate, a drug used to treat epilepsy and bipolar disorder.  Valproate is marketed under the brand names Depakote and Epilim, among others.

Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders.  If taken during pregnancy, up to four in ten babies are at risk of developmental disorders and approximately one in ten are at risk of birth defects.

It is thought that approximately 20,000 children in the UK have been left with disabilities caused by valproate since the drug was introduced in the 1970s.

Many women whose babies were affected say that they were not warned of the extent of the dangers to their unborn child, although scientific research as early as the 1980s suggested that valproate was dangerous to developing babies.

Annual specialist reviews

Any doctor who give valproate prescriptions to female patients of childbearing age must ensure that they are enrolled in the pregnancy prevention programme.   This means that:

  • The patient must be reviewed by a specialist at least once a year to discuss the risks;
  • She must sign an acknowledgement form to say that she understands the risk;
  • She must be told about the importance of using contraception throughout treatment and having a pregnancy test if there is a chance that she could be pregnant;
  • The patient must be referred for contraception services as needed.

All women and girls with valproate prescriptions should contact their GP to arrange a treatment review. It is important that patients do not stop taking valproate without first seeking medical advice. The MHRA says that the decision to use any medicine in pregnancy requires a careful evaluation of the benefits and risks to both the woman and her unborn child.

These new regulatory changes will be followed in the upcoming months by:

  • Smaller pack sizes to encourage monthly valproate prescriptions;
  • A warning image of valproate labelling;
  • New GP system computers alerts.

The National Institute for Health and Care Excellence is amending its guidelines to reflect the new regulatory  position.

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.

This regulatory position has been developed through close collaboration with professional bodies, health system organisations, and patient and campaign groups.”

If you have any questions in relation to this article or wish to discuss a potential clinical negligence claim, then please do not hesitate to get in touch with us by emailing the Head of Clinical Negligence Jane Lynch at jlynch@lyonsdavidson.co.uk or calling 0117 394 5012.

Posted on May 29th, 2018 by Lyons Davidson

By using this website you agree to accept our Privacy Policy and Terms & Conditions