The Commission on Human Medicines (CHM) has advised ‘greater scrutiny’ of valproate prescribing, as part of new safety measures to be introduced over the coming months, the MHRA has said.

In particular, under the measures, CHM advised prescribers not to initiate any patients (male or female) aged under 55 years on valproate, unless two specialists independently consider and document that there is no other effective or tolerated treatment.

Patients aged under 55 currently on valproate will also need to be reviewed by two specialists to independently consider and document that there is no other effective or tolerated treatment or the risks associated with the medication do not apply.

Sodium valproate, which is prescribed as a treatment for epilepsy and bipolar disorder, can cause birth defects in around one in ten babies born to those taking it while pregnant, and developmental problems in 30-40% of children whose mothers took the medicine while pregnant.

NICE guidance states that the medication ‘must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place’.

The CHM guidance also extends to male patients under the age of 55 as this age group is most likely to be affected by the possible risk of impaired fertility in males.

The MHRA said that the recommended measures will be introduced ‘over the coming months according to patient priorities so that they can be introduced safely’, following advice from the CHM’s implementation group and engagement with stakeholders.

It added that ‘no action is needed at present’, and that patients currently taking valproate must be advised not to stop taking it unless they are advised by a specialist to do so.

The MHRA also said that until the CHM’s recommendations are introduced, GPs and pharmacists should continue to provide repeat prescriptions for valproate and dispensers should continue to ensure patients receive the patient card, a copy of the Patient Information Leaflet and packaging bearing pregnancy warnings.

The CHM’s recommendations follow its review of safety data relating to valproate. This review included prescribing data which showed continued use of valproate in female patients and some use during pregnancy, with 17 new female patients prescribed valproate while pregnant between October 2021 and March 2022.

The MRHA said that although rates of valproate usage in female patients have declined since the introduction of the Pregnancy Prevention Programme in 2018, there had recently been ‘a plateauing of this decline’ and added that ‘there is no room for complacency’.

The CHM review also considered evolving information about potential risks in male patients, including evidence that valproate may impair male fertility, but that this may be reversible upon discontinuation.

It also considered views from patients and other stakeholders about how valproate is currently used and its risks currently managed.

In October, The General Pharmaceutical Council (GPhC) reminded pharmacists to ensure that women and girls prescribed sodium valproate are informed about the risks of taking it during pregnancy.

The GPhC said that it was ‘very concerned’ to hear from patient groups that women and girls prescribed sodium valproate were not always given the right information and advice about the drug by pharmacies supplying it, including important safety information relating to use in pregnancy.

It said that it has recently investigated instances of sodium valproate being dispensed by pharmacies in a white box with no safety warnings or Patient Information Leaflet.

But Leyla Hannbeck, CEO of the Association of Independent Multiple pharmacies (AIMp), told The Pharmacist in April that pharmacy teams should not be blamed, and that there were issues with the way that drug manufacturing and packaging did not align with GP prescribing patterns.

This comes following the first recorded death linked to taking valproate in pregnancy. Jake Aldcroft died age 21 in April after an infection triggered by problems with his kidneys, with foetal valproate syndrome listed as a contributing factor to his death. His mother said that she was never warned about the dangers of valproate when she took the epilepsy treatment during her pregnancy.