Sodium Valproate

Baroness Cumberlege Excerpts

Monday 5th June 2023 Lords Chamber

Asked by

[Baroness Cumberlege]

To ask His Majesty’s Government what further steps they are taking to protect patients and families from the harmful effects of sodium valproate taken during pregnancy, and what is their timetable for doing so.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

Our aim is to reduce and finally eliminate the harms of valproate in pregnancy. In December, we announced additional measures to protect women and families through a requirement for two prescribers, further warnings in the valproate product information, and improved educational materials. No woman of childbearing potential should receive valproate unless no other treatment is effective or tolerated. Implementation plans are now being finalised, with engagement with healthcare and patient organisations.

[Baroness Cumberlege (Con)]

My Lords, I thank my noble friend for that Answer. It goes some way, I think, to reassure many of us who have been very concerned about sodium valproate being given to pregnant women, and the result that that has had. I am seeking to ensure that, with the plain boxes which contain sodium valproate, those tablets are not actually opened without a clear warning, so that people know exactly what is contained in those boxes and the harmful effects it could have on their babies. Can the Minister tell me what is actually happening to those plain boxes, because sodium valproate should not be prescribed without a really clear warning about what it could do to babies and women?

[Lord Markham (Con)]

First, I thank my noble friend for all the vital work that she has done in this space. She is absolutely correct. The key thing is that there are circumstances where sodium valproate is the only effective treatment for bipolar and epilepsy-type disease problems. However, we have to ensure that if people are taking it, they are going into it with their eyes completely open, so that they fully understand the risks. That is absolutely to do with the packaging. It is also about making sure that if that packaging is split up there are leaflets in every part, and that everyone signs a consent form at least once a year, fully acknowledging the risks. Thereby, if people take the treatment, they are doing so with their eyes fully open.