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MHRA bans valproate prescribing for women not in pregnancy prevention programme

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1823 (Published 25 April 2018) Cite this as: BMJ 2018;361:k1823
  1. Gareth Iacobucci
  1. The BMJ

The Medicines and Healthcare Products Regulatory Agency (MHRA) has banned the antiepileptic drug sodium valproate in the UK in all women of childbearing potential who are not enrolled in a pregnancy prevention programme.

The regulator said that it had made the decision to protect public health and in close collaboration with professional bodies, NHS organisations, and patient and campaign groups.1

Women or girls who are already taking valproate should consult their GP to have their treatment reviewed, the MHRA said. But it added that no one should stop taking valproate without medical advice.

It highlighted evidence that children born to women who take valproate in pregnancy are at considerable risk of birth defects and persistent developmental disorders. If valproate is taken in pregnancy as many as four in 10 babies are at risk of developmental disorders, and around one in 10 are at risk of birth defects.

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.”

The MHRA said that its changes would be further supported in the coming months by smaller pack sizes to encourage monthly prescribing, a pictogram/warning image on valproate’s labelling, and new GP system computer alerts designed to ensure prompt changes in prescribing behaviour.

Alongside this the National Institute for Health and Care Excellence immediately amended its guidelines where valproate is mentioned, to reflect the new regulatory position.

James O’Shaughnessy, health minister, said, “Our priority is always patients’ safety, so I welcome this decision to take strong actions to protect women and children. The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.”

Helen Stokes-Lampard, chair of the Royal College of General Practitioners, said, “GPs are acutely aware of the risks associated with prescribing sodium valproate to women of childbearing age, and we welcome this change in legislation as a logical way forward to help ensure our patients’ safety. However, any patients currently taking sodium valproate should not stop doing so without seeking expert medical advice.”

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