Drug safety update for valproate in pregnancy

By Julie Griffiths on 20 December 2018 MHRA - Medicines and Healthcare Products Regulatory Agency Drug safety

There is a ‘wide variation’ in compliance with safety measures for the use of valproate, the Medicines and Healthcare Products Regulatory Agency (MHRA) says.

The MHRA has issued a drug safety update that urges all healthcare professionals to be sure that they are complying with pregnancy prevention when women are using valproate medicines. 

The update reiterates that valproate, which is used for the management of epilepsy or bipolar disorder and sometimes pain or migraine, should not be used in girls (of any age) and women of childbearing potential unless there is no suitable alternative.

It says that compliance by healthcare professionals with the new valproate measures for pregnancy prevention appeared to be ‘patchy’ and there was wide variation between Clinical Commissioning Groups (CCGs).

Healthcare professionals can check their region here.

It highlights that women are continuing to report instances when pharmacists have not provided a patient information leaflet or a patient card when dispensing valproate.

It also says that some women using valproate for off-label indications are not being reviewed in line with the new pregnancy prevention measures.

The MHRA said that all healthcare professionals must continue to identify and review all female patients on valproate, including when it is used outside the licensed indications (off-label use) and provide them with the patient information materials every time they attend their appointments or receive their medicines (including the patient information leaflet at dispensing).

Access the guidance here.