Valproate and Foetal Anticonvulsant Syndrome

Debate between Rosie Duffield and Fiona Bruce

Thursday 19th October 2017 Commons Chamber

[Fiona Bruce]

The hon. Lady makes a very good point.

Further warnings were issued. In 2000, a patient information leaflet from the producer, Sanofi, said:

“It is known that women who have epilepsy have a slightly higher risk of having a child with an abnormality than other women. Women who have to take Epilim in the first 3 months of pregnancy to control their epilepsy have about a 1-2% chance of having a baby with Spina Bifida.”

In 2005, Sanofi added:

“Some babies born to mothers who took Epilim during pregnancy may develop less quickly than normal and may require additional educational support”

and that some

“babies born to mothers who took Epilim…during pregnancy may develop less quickly than normal or have autistic disorders.”

Warnings were emerging over the years, but nothing was done to ensure that patients were told. Why did patients have to wait almost 30 years to be warned of the risks?

Janet Williams and Emma Murphy, whom the right hon. Member for North Norfolk (Norman Lamb) mentioned and whom I have had the privilege of meeting, are tenacious and brave women who have campaigned for years and set up a support group for affected families. I pay tribute to them, and I want to tell the House a little bit about their family situations. Janet has two sons aged 26 and 28: Lee and Philip. Janet took Epilim, but nothing else, during both pregnancies. She told me:

“I wasn’t offered anything else—and no one told me of the risks.”

Lee, at 26, has curvature of the spine, Asperger’s, learning difficulties and memory problems, and he cannot hold down a job. Philip, at 28, has even more problems. He has problems with hearing, vision, speech, language and walking, as well as floppy joints. He is still fully dependent on Janet.

Emma had her children a generation later. She has five children, aged eight to 14: Chloe, Lauren, Luke, Erin and Kian. They have all been diagnosed with a number of symptoms. All have varied problems, including autism, incontinence, deafness, cerebral palsy and curvature of the spine, and all are slow to develop. Emma took the same dose of Epilim during each pregnancy. She told me that she questioned that, but was told that it was the best drug to control her seizures and that her baby would be fine. She took no other drugs during her pregnancies. No one warned her of the risks.

The tragedy is that those two women represent more than 1,000 others in their support group, the Fetal Anti Convulsant Syndrome Association. Together, they founded the Independent Fetal Anti Convulsant Trust, a registered charity, to campaign for better awareness of the risks of taking valproate, to prevent further such difficulties occurring, and to challenge the Government. There is, as I say, a case to answer, and I do not believe that we would be here today were it not for these two women.

[Rosie Duffield (Canterbury) (Lab)]

Does the hon. Lady agree that women such as Janet and Emma are ideally placed to get compensation, should the Government agree to a system similar to the €10 million French compensation scheme for Depakine?

[Fiona Bruce]

I certainly think that has to be looked at as part of the case that Ministers have to answer.

I would like to say much more but time prohibits me. We have heard some of the terrible statistics that have already been cited about the 20,000 children who could have been affected since the risks were first known about, the 400 children who are still born each year with symptoms, the 28,000 women of childbearing age—according to ONS figures—who are still being prescribed the drug, and the 68% of women in this situation who say that they are not properly informed of the risks.

What do I ask of Ministers? I ask the Minister to agree that significantly more needs to be done urgently to raise awareness of the risks of taking sodium valproate among pregnant women and those who could become pregnant. Does he agree that although Ministers might have come to know about the risks only relatively recently, the producer Senofi, the MHRA and its predecessor, the Committee on Safety of Medicines, knew about them and should have done more to address them? They should have published information and improved warnings years ago.

Does the Minister accept that the support needed by mothers such as Janet and Emma, who have to care for their children with foetal valproate syndrome, is major and may be lifelong, and that much more needs to be done to consider how that support can be improved and funded? Janet and Emma tell me that the current provision through local councils and health authorities is wholly insufficient and that care plans are needed for the many affected children.

Is there any reason why, as I said at the outset, Ministers cannot look at what we in this country can do to support these families now, without further delay, and certainly without awaiting the final decision of the European Commission regarding the link between sodium valproate and birth defects? After all, we are leaving the EU. Does the Minister now have full confidence in the MHRA’s ability to effectively inform and guide healthcare professionals on the use of the prescription of sodium valproate for epilepsy, and does he think the same can be said of the MHRA’s involvement over the years? Finally, will the Minister, at an early date, meet Janet Williams and Emma Murphy, as well as a group of Members who are concerned about this issue, to respond to their concerns and to my call that our Government at the very least have a case to answer?