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TX: 30.09.03 – GOVERNMENT WARNS DOCTORS THAT EPILEPSY DRUG COULD CAUSE BIRTH DEFECTS – 20 YEARS AFTER FIRST WARNINGS WERE RAISED


PRESENTER: JOHN WAITE

WATE
It's been called the new thalidomide and now more than 20 years since the first warnings were raised about the dangers of giving the epilepsy drug Epilim to women likely to become pregnant the government has finally issued a warning to doctors not to prescribe it. The committee on safety of medicines says the risk of birth defects are two to three times higher in epileptic women who take Epilim, which is also known as sodium valproate. There are currently 170,000 women with epilepsy in the UK of childbearing age and around a hundred people are taking legal action after having had children with spina bifida or birth defects like facial deformations or missing limbs.

Well we can talk now to ProfessorGordonDuff, who's the head of the Committee on Safety of Medicines, he's on the line to us from his office in Sheffield. Professor Duff you've known about these problems, as I say, for years, for 20 years, why has it taken so long to issue this warning to GPs and specialists?

DUFF
Yes well it's not that it's taken this long to issue the warnings, because in fact warnings to prescribers about the possible effects of valproate in pregnancy have been available since 1983 and were reinforced in 1993 in Current Problems in Pharmacovigilance. But you're question is a good one because it has to be understood that uncontrolled epilepsy in a pregnant woman does pose an enormous risk to the unborn child. So it is always a question of balancing that risk against the risk of treatment. And although we have known about a possible association for many, many years it has never actually been possible or easy to disassociate the risk of the disease on the formation of the unborn child to the risk of the drugs. But towards the end of last year further information was becoming available that seemed to strengthen the evidence that there might be a causal link.

WAITE
Yes, you accept two studies show this increased risk for pregnant women, what problems have we been seeing?

DUFF
Well it's known that the women on anticonvulsant drugs and on sodium valproate, as you mentioned earlier, have a higher risk of having children with malformations and spina bifida, for example, would be one of them. The thing to say though I think is that at this point the Committee on Safety of Medicine, I'm talking now about the end of last year, did take an expert working group - put an expert working group together to review the new evidence and to advise the committee. And the advice of the expert working group was to make changes to the warnings given to prescribers and to the patient and the patient information leaflet. But these were essentially strengthening warnings that had already been there and it's by no means a recommendation not to use the drug in epilepsy - I think that's an important point.

WAITE
Well just let me bring in, if I may, on the line from his clinic in Birmingham Dr Tim Betts, a consultant neuropsychiatrist and an expert in epilepsy. Dr Betts what's your reaction to this restriction on this drug?

BETTS
I think in terms of women it's the right thing to do. I think what the professor is saying is quite right, that Epilim is actually an extremely effective anticonvulsant drug and for men we'll certainly go on using it.

WAITE
But you've not been prescribing this drug, have you, for years?

BETTS
Not for women no, for 10 years we've been using other drugs and I'm pleased to say you don't have to use it in women who wish to become pregnant.

WAITE
So there are alternatives?

BETTS
There are alternatives.

WAITE
So these hundred women or so, who've had babies with birth defects, could that in your view have been avoided?

BETTS
Most of it, I mean occasionally Epilim is going to be the only drug that will control the woman's seizures and the professor is quite right, you need good seizure control during pregnancy. But most of them, yes, it probably could have been avoided.

WAITE
Now NICE - the National Institute for Clinical Excellence - is about to issue guidance on epilepsy drugs, does this finally clear things up about this drug, about Epilim, do you think?

BETTS
Well my understanding is of course the NICE process is still going on, up until now they've not made a distinction in terms of women. I think they will have to because the evidence is now very clear, this drug should not be used in women who wish to have children.

WAITE
Because at the moment, and I've got the draft - the NICE draft - in front of me, this drug is a drug of choice in primary generalised epilepsy, it says, and it says that most babies born to women on anti-epileptic drugs will not have a malformation. It doesn't sound much of a warning.

BETTS
No I think they will probably have to change it in light of this new evidence. It certainly isn't a drug that a woman who wishes to have children - and that's 40 per cent of people with epilepsy - would want to take unless it was the only drug that would work.

WAITE
Professor Duff do you think NICE issuing these guidelines will have to strengthen them and bring in more of a warning element about Epilim?

DUFF
Well I haven't had the advantage of seeing the draft report from NICE. I don't feel particularly confident on commenting on it. But to - just to pick up one of the points, the warnings that CSM has strengthened essentially say that women of childbearing potential should not be started on this drug in the absence of specialist neurological advice. Now that advice, which would be the best clinical practice in the view of the specialist, is really where everything balances. From the regulatory point of view the CSM has not recommended a ban on this drug at all but has just increased the strength of the warnings and the level of information that patients should have so that they can take part in making a rational decision on what is truly a very difficult area.

WAITE
But don't you think you should push NICE to strengthen its guidelines?

DUFF
Well …

WAITE
So you don't have more - you've just heard Dr Tim Betts - so you don't have more women having children with birth defects that could be avoided?

DUFF
Well it may or may not be true that there are more women with birth defects and it may or may not be true that they could be avoided because presumably they would be taking some other form of anti-epileptic control or indeed would be at risk of having uncontrolled epilepsy, which is itself a danger to the unborn child.

WAITE
Dr Betts, if I could just come back to you quickly and finally, many women will be taking this drug at the moment, what's you advice to them?

BETTS
Don't panic, discuss it with your doctor. The problem is if you are taking Epilim and choose to transfer to another drug it's not the easiest thing to do and your doctor will need expert advice.

WAITE
So it's dangerous just to stop taking it, you must discuss this with your doctor?

BETTS
Extremely dangerous just to stop.

WAITE
Dr Tim Betts, Professor Gordon Duff, thank you both.

BETTS
Thank you very much.




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