First do no harm: valproate and medicines safety in pregnancy

INTRODUCTION

On 8 July 2020, following a 2-year independent inquiry, Baroness Julia Cumberlege published her report First Do No Harm,¹ looking into sodium valproate, pelvic mesh, and Primodos oral pregnancy tests, and the resulting harm to women and their children: ‘We have found that the healthcare system ... is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.’ ¹

The report is highly relevant to medicines safety in relation to women’s health and pregnancy. This editorial concentrates on valproate, a medicine prescribed by GPs, with relevance for other commonly prescribed teratogenic medicines. Primodos is no longer used but there will be women cared for in general practice, including those affected by pelvic mesh use, for whom this report is also highly relevant.

The 268-page report documents the protracted history of harms of valproate with similarities to thalidomide, which affected 10 000 surviving children worldwide.² Thalidomide is now part of an historic lesson online at the Science Museum, and similarities with valproate are striking.² Valproate, licensed in 1972 despite early concerns of teratogenicity, had clear evidence of physical malformations by 1984, with over 20 000 exposed pregnancies to date in the UK alone.¹ Forty per cent of these were likely to have been associated with significant neurodevelopmental or physical harm to the children.¹ The report highlights themes common to both tragedies including early signals of concern, multiple and systematic organisational failures, including …