PARLIAMENTARY DEBATES - United Kingdom Parliament

443WH
Fetal Anti-convulsant Syndrome
26 MARCH 2013
Fetal Anti-convulsant Syndrome
444WH
[Anna Soubry]
I concede that it is never attractive for a Minister to
begin opening remarks by saying, “This particular issue
is not within my brief.” Immediately, it sounds like
trying to pass the buck to somebody else. However,
notwithstanding that the issue is not within my brief—I
am standing in for the Minister with responsibility, who
is unfortunately unable to attend this debate—I assure
the hon. Gentleman that on my return to the Department
of Health, I will speak to the Minister’s officials and
ensure that they are fully aware of all the matters that
he has raised and the many questions that he has rightly
posed, some of which I will be able to answer. I will
ensure that all the answers are given, if not by me today
then certainly in a letter.
I will speak directly with the Minister of State,
Department of Health, my hon. Friend the Member for
North Norfolk (Norman Lamb). Knowing him as I do,
I am sure that he will be keen to meet the hon. Gentleman.
It might take a little time—our diaries, as one might
imagine, are fiendishly full—but I can see no good
reason why my hon. Friend would not want to know
more about the issue. Anybody hearing the hon.
Gentleman’s speech, the arguments advanced and the
stories behind this unfortunate condition would want to
know more and to see whether anything can be done.
What we do know is that fetal anti-convulsant syndrome
can occur when a mother must take anti-epilepsy drugs,
as the hon. Gentleman has explained better than I can.
We know that it can result—although, it is important to
say, not always—in delays in developing speech and
language skills in the babies born, difficulties with social
interaction, memory and attention and physical defects
such as spina bifida, heart defects, ocular abnormalities
and characteristic facial features.
It is important to say that most women with epilepsy
will have successful pregnancies and healthy children.
However, epilepsy during pregnancy can pose challenges.
Epilepsy is associated with the risk of giving birth to a
disabled child, and for women on anti-epilepsy drugs,
the risk is greater. Pregnancy may also increase the
frequency of seizures in about one third of women, and
it can alter their metabolism of AEDs. Prolonged fits
can be dangerous for the baby as well as the mother, so
ideally, pregnant women should be seizure-free.
The hon. Member for Glasgow Central rightly made
the point that women have been diagnosed and prescribed
this treatment, and he argued that they have not had
sufficient explanation of the risks involved in continuing
to take that form of medication, which many epilepsy
sufferers take without any difficulty, for the sake of
their health because of its positive effect.
I commend my hon. Friend the Member for Lancaster
and Fleetwood (Eric Ollerenshaw) for the important
point he made about the role of general practitioners in
ensuring that National Institute for Health and Clinical
Excellence guidelines are followed. I have those guidelines
in front of me and what they say is important. It is all
well and good that the pros and cons of the medication
are set down, but it is also imperative for GPs and
everyone else involved in the treatment of a woman
with epilepsy who is thinking of becoming pregnant or
is of childbearing age to understand the potentially bad
consequences of taking AEDs throughout a pregnancy.
Such women need proper information and a full and
frank discussion so that they can make an informed
choice—I emphasise that it should be an informed
choice—before and during pregnancy.
The NICE guidelines are clear:
“In women of childbearing age, the risk of the drugs causing
harm to an unborn child should be discussed and an assessment
made as to the risks and benefits of treatment with individual
drugs…In girls of childbearing age, the risk of the drugs causing
harm to an unborn child should be discussed between the girl
and/or her carer”—
in most cases, a parent—
“and an assessment…made as to the risks and benefits of treatment
with individual drugs…Prescribers should be aware of the latest
data on the risks to the unborn child associated with AED
therapy when prescribing for women and girls of childbearing
potential…Specific caution is advised in the use of sodium valproate
because of the risk of harm to the unborn child”.
The NICE guidelines could not be more clear, but
proper information sharing and full and frank discussion
are critical to informed choices.
Anas Sarwar: I thank the Minister for reading out the
NICE guidelines, which I have also read. When that
system fails, however, as it clearly has for so many years,
affecting thousands of families, what happens then?
Anna Soubry: Indeed. I was about to move on to that
very point, which was also made by the hon. Member
for Strangford (Jim Shannon), and to discuss support
for children who have such an affliction, obviously
through no fault of their own or of their mother. Before
I do so, let me add that data related to the safety and
use of AEDs during pregnancy remain under scrutiny;
the information and the advice are updated and issued
as appropriate. The MHRA regularly reviews both the
evidence on AED use in women of childbearing age
and the information provided in the product information
and in patient information leaflets—although many
people think that we are lucky if anyone reads leaflets in
boxes, and that they are not the way to convey information
to a patient; they are no substitute for sitting people
down and telling them face to face, going through
everything in the manner I have described. The important
fact is that we are continually scrutinising the information
and advice so that it is regularly updated.
On the specific point about children with this unfortunate
condition, better care and outcomes for disabled children
are a priority of the Government. The mandate to the
NHS Commissioning Board sets out our ambition to
give children the best start in life and to promote their
physical and mental health and their resilience as they
grow up. At national level, the new Children And
Young People’s Health Outcomes Board will bring together
what my brief describes as key system leaders in child
health to provide a sustained focus on improving outcomes
throughout the child health system. The Children and
Young People’s Health Outcomes Forum will provide
continuing expertise in child health and offer constructive
challenge as we take forward plans to improve the
system.
Those are fine words, though the brief was not written
by me—it is not in the nice, clear, plain English that I
would like. When I return to the Department of Health,
however, I will make the point that, given the structures
and our good, strong ambitions, it is imperative for us