Date lodged: 4 January 2018
To ask the Scottish Government what action it is taking to ensure that women who are prescribed sodium valproate are (a) adequately counselled regarding the risks of taking the drug while pregnant and (b) supported to plan their pregnancies in order to minimise the risk of foetal abnormalities.
Answered by: Shona Robison 18 January 2018
Regulation for the licensing, safety and efficacy of medicines is currently reserved to the UK Government and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA) who operate on a UK wide basis. The Scottish Government has ensured that all relevant advice issued by the MHRA to highlight the risks associated with taking Sodium Valproate have been circulated to healthcare professionals in Scotland. This includes strengthened warnings and educational materials.
The Scottish Government will continue to work closely with the MHRA. This will include discussion on any outcomes from the current European wide review considering the effectiveness of measures taken so far and whether further regulatory measures are required to minimise risks of foetal abnormalities in girls and women of childbearing potential.