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Sodium valproate

Volume 712: debated on Tuesday 19 April 2022

The petition of residents of the United Kingdom,

Declares that many families have been greatly and negatively impacted by the use of sodium valproate in pregnancy which has impacted many children for the rest of their lives; and notes that the Cumberlege Review, written by Baroness Julia Cumberlege, found that the use of sodium valproate in pregnancy has been linked to an increased risk of developmental problems, spina bifida, hare lip, cleft palate, limb defects and other serious birth defects.

The petitioners therefore request that the House of Commons urge the Government immediately implement, in full, every recommendation in the Cumberlege Review.

And the petitioners remain, etc.—[Presented by Cat Smith , Official Report, 1 March 2022; Vol. 709, c. 1011.]

[P002715]

Observations from the Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield):

The Government published their response to the Independent Medicines and Medical Devices Safety Review (the “Review” (also known as “the Cumberlege Review”)) on 21 July 2021. The Government accepted the majority of the Review’s nine strategic recommendations and 50 actions for improvement.

The Government did not accept two of the Review’s recommendations:

recommendations 3 and 4, which called for the establishment of a redress agency and separate redress schemes for those who have been affected by pelvic mesh, sodium valproate and hormone pregnancy tests. The reasons for this are set out in the Government response, which include focusing efforts to improve the future safety of medicines and medical devices. The Government have no plans to revisit this position.

The Government are committed to making rapid progress on all areas set out in their response. Work is well under way to implement the accepted recommendations, which includes legislating for the first Patient Safety Commissioner and setting up nine specialist mesh centres for those who have been adversely affected by implanted mesh. As set out in the Government response, the Government aim to publish an update on progress to implement the accepted recommendations in summer 2022.

The Government recognise the adverse impact that sodium valproate, when taken by mothers during pregnancy, has had on the lives of women and their families. The Government are taking forward a programme of work to ensure that sodium valproate is only prescribed when clinically appropriate. The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented a strengthened regulatory position on sodium valproate, which includes ensuring that valproate is not prescribed to a woman or girl who is able to have children, unless she is fully aware of the risks and understands the need to avoid becoming pregnant.

Future safety of sodium valproate is managed by the Medicines in Pregnancy Valproate Registry (the Registry). The Registry currently includes all women in England who are receiving NHS-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. Work is ongoing to understand how to extend the Registry to all women in each of the Home Nations.