Valproate and Foetal Anticonvulsant Syndrome

Debate between Fiona Bruce and Liz McInnes

Thursday 19th October 2017 Commons Chamber

[Liz McInnes]

The hon. Lady is absolutely right. She and I are well aware of the yellow card system, because we have both worked in the NHS, but how many people out there know that they can report side-effects of drugs, or even suspected side-effects? We really have a job to do in conveying that message to the general public, and we also need people to collate the information and act on it.

A definitive paper stating that there was a clear link between valproate taken during pregnancy and birth defects was published in 1995. It was entitled “Foetal Valproate Syndrome”, and was written by geneticists at St Mary’s Hospital, Manchester. It is clear that the evidence has been building up for a long time, so why does it appear that women were not warned about the potential dangers of taking the drug in pregnancy?

[Fiona Bruce]

That 1995 report concluded that the “risk” of foetal valproate syndrome when babies were exposed to valproate was “significant”.

[Liz McInnes]

That was probably the first research paper to suggest that it was not just coincidence and that there was a causal relationship, which is why it is seen as definitive.

The pharmaceutical company Sanofi, which many Members have mentioned, has stated that it has kept in line with scientific knowledge when reporting side-effects in a foetus. However, from as early as 1983 the CSM and the MHRA reported the problems caused by taking sodium valproate in pregnancy, but did not insist that Sanofi issue warnings in the form of a patient information leaflet.

Even now, to this day, epilepsy charities report that women are not aware of the potential risks when taking the drug in pregnancy. A survey has shown—I know it has already been mentioned, but it does no harm to reinforce these findings—that 18% of women taking sodium valproate were not aware of the risks during pregnancy, and 28% said that they had not been informed of any risks. That is despite the production by the MHRA of a valproate toolkit designed to help healthcare professionals to talk to women with epilepsy about the risks of taking valproate during pregnancy.