VALPROATE medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place, according to new guidance from the Medicines and Healthcare products Regulatory Agency.
The MHRA is urging healthcare providers to ensure all women and girls (and their parent(s), caregiver or responsible person) are fully informed of the risks and the need to avoid exposure to valproate, which is used primarily to treat epilepsy and bipolar disorder.
Valproate has been found to be highly teratogenic with evidence that use in pregnancy leads to physical birth defects in 10 in every 100 babies (compared with a background rate of 2 to 3 in 100) and neurodevelopmental disorders in approximately 30 to 40 in every 100 children born to mothers taking the drug.
Valproate medicines should not be used in girls and women of childbearing potential unless there is no suitable alternative as judged by a specialist experienced in the management of epilepsy or bipolar disorder. The National Institute for Health and Care Excellence (NICE) has updated clinical guidelines relevant to valproate medicines to reflect the regulatory changes.
GPs are being urged to identify and recall all women and girls of childbearing potential who may using the drug and provide a patient guide and check they have been reviewed by a specialist. Patient guides are being supplied as part of a Pregnancy Prevention Programme with materials (also including a healthcare professional guide and risk acknowledgement form) being posted in the coming weeks to use in the implementation.
Specialists must book in review appointments at least annually with women and girls under the Pregnancy Prevention Programme and re-evaluate treatment as necessary and explain clearly the conditions as outlined in the supporting materials. They must then complete and sign the risk acknowledgement form, with copies given to the patient or caregiver and sent to their GP.
A visual warning symbol will be added to cartons of valproate medicines by September 2018.
For more information see the MHRA alert: Valproate use by women and girls