Support Alert

Drug safety update: Valproate medicines contraindicated in women and girls of childbearing potential

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update: Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme (PPP) are met. Ensure all women and girls (and their parent, caregiver, or responsible person, if necessary) are fully informed of the risks and the need to avoid exposure to valproate medicines in pregnancy. 

Pharmacists are reminded of the risks of stopping valproate medicines suddenly, which has as a risk of status epilepticus and sudden unexpected death. Pharmacists should not refuse supply of the medication, if after a conversation with the patient you discover that they are not on a PPP. If the patient is not on the PPP the pharmacist should advise them to continue taking their medicine and make an urgent appointment with their doctor to review treatment. See RPS Dispensing Valproate for girls and women QRG (this guidance will be updated to align with the latest MHRA Drug Safety Update).

Actions for pharmacists and further information can be found on the MHRA website.  

The Chief Medical Officer has written today to all healthcare professionals in England via an alert issued through the Central Alerting System to advise them of the changes and her expectation of the actions they are required to take. A pdf copy of the CMO’s letter to healthcare professionals in England can be accessed directly here