MHRA issues update on the Valproate Pregnancy Prevention Programme

Posted 29 January 2020

Date: 29 Jan 2020

Type: Sexual and Reproductive Health News

Read the full update below:

Update - Valproate Pregnancy Prevention Programme

Healthcare professionals involved in the care of female patients on valproate medicines in the UK should be vigilant for the arrival of letters from Sanofi containing updated educational materials. Continue to use these educational materials to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.

In 2019 the Annual Risk Acknowledgement Form and Guide for Healthcare Professionals were updated in collaboration with the MHRA after involvement with other stakeholder groups. Also updated are the Patient Card and Patient Guide to be provided to female patients on valproate medicines. Pharmacies are also advised of the updated dispensary poster and white box warning labels. Changes in the materials were made to clarify the existing regulatory situation and not due to new advice.

The letters containing the materials are being distributed to specialists and other healthcare professionals (via post) and pharmacies (via Tote boxes) in January 2020. For more about the Valproate Pregnancy Prevention Programme, see Drug Safety Update from April 2018.

Click here to read this update online.