Fetal Anti-convulsant Syndrome

Jim Shannon Excerpts

Tuesday 26th March 2013 Westminster Hall

[Anas Sarwar (Glasgow Central) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am delighted to have secured this important and topical debate after months of bad luck in the ballot. The House will adjourn for the Easter recess today, and I appreciate the effect of that on the number of participants. As hon. Members have other commitments in their constituencies, the turnout is lower than it would have been had the debate taken place at a more convenient time, so I am grateful to colleagues who have made it here.

Members who watched the recent BBC “Inside Out” programme will recognise the timeliness of this debate, because new expert medical research has highlighted the dangers of anti-convulsant medication to pregnant women and their unborn children. Before we get into the debate, I will provide a bit of background information on fetal anti-convulsant syndrome and the Independent Fetal Anti-Convulsant Trust.

Fetal anti-convulsant syndrome is a medical condition that arises among the children of mothers who suffer from epilepsy and take a type of drug known or used as an anti-convulsant medication to treat their condition during pregnancy. Not all children who are exposed to anti-convulsant drugs are affected. The level of risk is determined by known factors, such as the particular anti-convulsant medication used and the dose taken, as well as other susceptibility factors. Children suffering from fetal anti-convulsant syndrome suffer from a constellation of physical and neuro-developmental deficits, and so have to be diagnosed by a medical specialist.

The Independent Fetal Anti-Convulsant Trust was launched in November 2012 to gather information and provide support and assistance to those affected by the condition. It is run by a small, hard-working team of volunteers, a couple of whom are in the Gallery today. I would like to put on record my thanks to the entire team, and especially to Janet Williams, who has done a fantastic job in providing me and many other hon. Members with so much invaluable information. I would urge anyone who suffers from the condition, or who has a relative or friend with it, to contact the trust.

It is difficult to get an accurate picture of the number of people affected by the condition; in response to a parliamentary question to the Department of Health on the number of women receiving anti-epileptic drugs through the NHS, I was unfortunately told that the information was not available centrally. Things are made even more difficult by the fact that many children with the condition will not have been diagnosed with the syndrome because they do not have a major congenital malformation, such as a heart defect or spina bifida. Those children are less likely to be referred to a clinical geneticist.

Sodium valproate is the drug that reportedly carries the largest risk of causing fetal anti-convulsant syndrome. According to prescription records, there were more than 21,500 women taking sodium valproate in 2010 in England and Wales alone. A range of scientific studies conducted over the past couple of decades have demonstrated that some 10% of children exposed to sodium valproate will be born with a major congenital malformation. Their IQ is likely to be lower than it otherwise would have been, with 29% requiring additional educational support and 6% being diagnosed with significant social communication difficulties, such as autism.

More broadly, there have been numerous case reports in medical journals of children born with one or more major birth defects when the mother had been taking anti-convulsant drugs. Those children include not only those born with spina bifida and heart defects, but those born with cleft palates, limb malformations, neuro-developmental delays and learning difficulties. There are therefore likely to be tens of thousands of children affected by the condition.

[Jim Shannon (Strangford) (DUP)]

The hon. Gentleman is making his case very well. Fetal anti-convulsant syndrome is an unknown quantity that affects children. I am aware of a family in my constituency with children who suffer from it. The hon. Gentleman has not yet mentioned that children may also suffer from autism as a result of fetal anti-convulsant syndrome. Is he aware of that? Does he feel that more research is needed to find the necessary treatment, and that the Government should respond by encouraging, and making moneys available for, a treatment to be found for those young people and their parents?

[Anas Sarwar]

I did in fact mention autism, but the hon. Gentleman is absolutely right that we need direct support from the Government to help families affected by this condition.

The campaign has identified 500 families, but there are likely to be thousands of families across the country who do not know that their child suffers from this condition, and who do not have support from an organisation such as the trust. We therefore need Government action to support those families at this difficult time. The Organisation for Anti-Convulsant Syndromes—of which Janet Williams, who I mentioned earlier, was a founder—has been contacted by more than 500 families, with nearly 700 individuals affected by the condition.

The drug sodium valproate, which is manufactured under the name of Epilim by Sanofi, has been prescribed in the UK since the 1970s. Despite the drug’s efficacy in treating certain types of seizure, research has demonstrated that it carries a higher risk to the exposed foetus than other drugs. The first case reporting the effects of sodium valproate during pregnancy appeared in 1981, and it grew to be a hot topic within the medical profession in the 1980s, with numerous reports appearing in the medical journals. The report, however, was never investigated in the review of medicines from 1971 to 1990. The then Medicines Control Agency, which became the Medicines and Healthcare products Regulatory Agency in 2004, did not pursue the claims made by the medical research community. The MHRA “Current Problems in Pharmacovigilance” reports addressed the effects of sodium valproate in January 1983 and continued to do so intermittently. No action was taken, however, to convince Sanofi to recall the drug, improve it, or provide comprehensive warnings to patients and their doctors.