Valproate and Foetal Anticonvulsant Syndrome — House of Commons, 2017-10-19
Topic: Health
Fiona Claire Bruce (Conservative, Centre-right): I pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for so eloquently articulating the concerns that many of us share about the taking of sodium valproate by expectant mothers I am speaking today because I believe there is a case for Ministers to answer on the grounds of compassion and justice as to how and why pregnant women were allowed to take sodium valproate for so many years without being better advised and informed, and without their unborn children being better protected from the risks. That is particularly the case since professionals became increasingly aware of those risks over the years—as early as 1973. As we have heard, the risks are huge. At the end of the day, the people who should have been able to weigh them up and choose whether to take valproate while pregnant were the mothers. I appreciate that in 1973 we were, as has been said by a practitioner in medicine, in a more paternalistic era, but that was not the case as the years went by, and certainly not in 2016, when the valproate toolkit—the patient guide that I have here in my hand—was published Mothers were not given the relevant information and, sadly, far too many still are not. It is absolutely critical that they are given it, because the toolkit is stark, stating: "If you take valproate when you are pregnant it can harm your unborn child…Taking valproate…can cause birth defects and problems with development and learning…In women who take valproate while pregnant, around 10 babies in every 100 will have a birth defect", such as "spina bifida…facial and skull malformations…malformations of the limbs, heart, kidney" and other organs. It goes on to say that "about 30-40 children in every 100 may have developmental problems" such as "learning to walk and talk…lower intelligence…poor speech and language skills" and "memory problems." It states that "it is…important that you…know about these risks" But for years women did not know about the risks when medical professionals did. They might not have known, and probably did not know, all those details. However, I have with me a copy of a letter from the Committee on Safety of Medicines—the precursor to the MHRA—from 1973. It refers to a number of studies and says: "it is now clear from other studies…that the use of anticonvulsants during pregnancy…is liable to produce other abnormalities as well as hare-lip and cleft palate. The risk appears to be low and not sufficient to justify stopping the use of anticonvulsants when they are necessary for the control of epilepsy." There we have it—the Committee on Safety of Medicines was aware of this in 1973. The documentation relating to the licensing application in 1974, which the right hon. Gentleman mentioned, says that the product is licensed "for use in general, focal or other epilepsy. In women of child bearing age, it should only be used in severe cases or those resistant to other treatment" So we now know that the dangers were being raised as long ago as 1973 and 1974 In response to these concerns, the CSM instructed that an alert must "not go on the package inserts" so that patients would be protected from "fruitless anxiety". Because patients did not see anything, they were denied the information and therefore the choice to abstain from this drug. Yet very much more anxiety was caused for many of them when the reality was that thousands of babies were born with life-changing disabilities and deformities that could have resulted from taking this drug during pregnancy.