Safety warnings to be provided to all patients with every valproate-containing medicine

Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy.

The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines.

A large majority of respondents to the consultation – 85% – agreed or strongly agreed with the requirement that the full-pack dispensing of medicines containing valproate in the manufacturer’s original pack will ensure patients always receive the safety information supplied on the label and in the Patient Information Leaflet.

MHRA Chief Executive, Dr June Raine, said: “It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed. The changes in the law announced today ensure this happens. People’s situation may change, especially with regard to the possibility of pregnancy, so it is vital that the warnings about the harms of valproate are always brought to mind.

“We are pleased to provide guidance to support the further strengthening of safety warnings around dispensing and we ask all dispensers of medicines containing valproate to consult the new guidance carefully."

View the new guidance for dispensers