An epilepsy drug that causes birth defects should not be banned during pregnancy, researchers argue.
According to the consultant neurologists Heather Angus-Leppan and Rebecca Liu, from the Royal Free London NHS Foundation Trust, the controversial medication sodium valproate may be the only effective treatment for certain patients.
They add untreated epilepsy can seriously harm both pregnant women and their unborn children. Previous research suggests seizures increase in expectant mothers, particularly in their third trimesters.
The European Commission is considering whether to ban the drug in pregnant women.
Sodium valproate controls electrical functions in the brain to prevent life-threatening seizures, with Sanofi’s Epilim typically being a go-to brand in the UK and Ireland.
The drug previously came under fire when MailOnline reported three mothers blame the drug for leaving their children with autism, learning difficulties and incontinence after doctors failed to warn them of its risks during pregnancy.
Around 20,000 children in the UK have been affected by the drug, according to campaigners.
NICE data reveals the drug raises the risk of babies suffering serious developmental disorders by up to 40 per cent and malformations, such as cleft palates or lips, by 11 per cent, if it is taken during pregnancy.
An epilepsy drug that causes birth defects should not be banned, researchers argue (stock)
HOW MANY CHILDREN SUFFER?
Out of around 35,000 women aged 14-to-45 taking sodium valproate between 2010 and 2012, at least 1,125 were pregnant.
If 450 babies are born every year to mothers taking the drug, up to 45 could have a physical disability and up to 180 may suffer from learning difficulties.
Between 1993 and 2008, there was a 20 per cent reduction in the number of women aged 15-to-55 who were taking sodium valproate due to new treatments being available.
The Medicines and Healthcare products Regulatory Agency says sodium valproate should not be given to women of a childbearing age or during pregnancy unless alternative treatments are ineffective or not tolerated.
Yet, in 2016, around 450 babies were born to mothers taking the drug during pregnancy.
Source: Epilepsy Society
Banning sodium valproate denies women an effective treatment
Writing in the BMJ, Dr Angus-Leppan and Dr Liu said banning valproate ‘imposes less effective treatment for some female patients than for other people with a similar life-threatening or serious condition, without their consent.’
Earlier this year, the European Medicines Association recommended sodium valproate should only be prescribed to women of a childbearing age if they agree to use contraception, which Dr Angus-Leppan and Dr Liu wrote ‘could be considered an infringement of patient autonomy and liberty’.
They warn that women who are taking sodium valproate without medical supervision are at particular risk of giving birth to babies with birth defects, adding scaremongering ‘may result in women stopping their treatment without support’.
Dr Angus-Leppan and Dr Liu add further research is required to find a sodium valproate alternative.
Yet, in the meantime, women should be given specific information about the medication’s benefits and risks to help them make informed drug-taking decisions alongside their doctors.
Around 20,000 children in the UK have been affected after their mothers took the drug (stock)
‘It has taken half a century to understand valproate’s harm’
If the European Commission imposes a partial sodium valproate ban, women of a childbearing age who are prescribed the drug will be reviewed regularly and must follow a pregnancy-prevention programme.
Sodium valproate packaging must also carry a visual warning of the drug’s pregnancy risks, with patients also receiving a warning card with each prescription.
Women who are pregnant and already taking sodium valproate should be urgently reviewed by a specialist.
In an accompanying editorial, consultant perinatal psychiatrists Angelika Wieck and Sarah Jones, from the Greater Manchester Mental Health NHS Foundation Trust, wrote: ‘It has taken half a century since valproate was first introduced to understand the full extent of harm to unborn children.’
‘Current regulatory systems are clearly inadequate at identifying and assessing the reproductive risks of medicines.
‘We urgently need a regulatory system for the standardised and timely collection of pregnancy outcome data for new and existing drugs that may harm offspring.
‘Mandatory pregnancy registers, targeted data mining of other resources, and regular evaluation of all available evidence would be key elements to achieve this aim.’
TIMELINE OF EVENTS FIGHTING TO STOP THE PROBLEM
In 2014 The European Medicines Agency agreed to strengthen warnings and restrictions on sodium valproate’s use in women and girls.
The Medicines and Healthcare Regulatory Agency (MHRA) advised healthcare professionals not to prescribe the drug to females unless other treatments are ineffective or poorly tolerated.
On February 8 2016, the MHRA launched a toolkit to help healthcare professionals talk to women with epilepsy about sodium valproate’s risks during pregnancy.
Prominent written warnings were also added to the drug’s packaging in 2016.
On April 6 2017, NHS Improvement and the MHRA sent a Patient Safety Alert through the central NHS system to further highlight sodium valproate’s risks during pregnancy.
A public hearing was held in London on 26 September last year by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee where EU citizens spoke of their experiences of the medication.
Why is sodium valproate controversial?
In September last year, campaigners presented evidence to a hearing of the European Medicines Agency in London, revealing that drug regulators knew of the problems as far back as 1973 but did not add warnings to its packaging until 2015.
Last January it emerged a professor from the University of Liverpool is studying a boy affected by sodium valproate syndrome to determine if he developed the condition as a result of his grandmother taking the drug during pregnancy.
FACS Aware, which campaigns for sufferers of foetal anti-convulsant syndromes, is fighting for all drugs containing sodium valproate to have a picture warning against their use during pregnancy on their packaging, as well as increased support for sufferers and better awareness among healthcare professionals.
Michael Szumera, head of communications at Sanofi, previously told MailOnline: ‘Valproate has at all times been supplied by Sanofi in the UK with a warning of the risk of malformations in babies born to mothers with epilepsy who take the product during pregnancy.
‘The product information for valproate (including the addition of warnings on the package labelling) has at all times been approved by the regulatory authorities as properly reflecting current scientific and medical knowledge before being put into circulation.
‘Sanofi has systematically reminded patients via the information document that they should consult their prescribing physician in case of pregnancy or desire for pregnancy so that their physician can act accordingly.’
WOMEN LEFT IN THE DARK OVER SODIUM VALPROATE’S RISKS
The risks of pregnant women taking sodium valproate were kept from patients for 40 years, a hearing was told.
In September last year, campaigners presented evidence to a hearing of the European Medicines Agency in London, revealing that regulators knew of the problems as far back as 1973.
Even the drug’s manufacturer Sanofi was open about the risks.
Yet documents show UK officials decided at the time not to put the warnings on the packets for fear it ‘could give rise to fruitless anxiety’, the hearing was told.
It was not until 2015 that clear warnings were published.
Catherine Cox, from the Foetal Anti-Convulsant Support Association for the UK, said: ‘These warnings could have and should have been given in 1974.
‘A decision was taken not to publish them despite warnings by the manufacturer.’
Health professionals were told at the time: ‘This compound has been shown to be teratogenic in animals, meaning it could harm the human foetus.;
Yet the Committee on Safety of Medicines, which existed before the MHRA, said the warning should ‘not go on the package inserts, so that there would be no danger of patients themselves seeing it,’ according to documents seen by Sky News.
Dr Eric Teo, who is in responsible for drug safety at Sanofi, told the hearing: ‘Sanofi had always provided the most up to date scientific information, with the approval of the health authorities.
‘There is a consent form for doctors to review with patients, there are patient cards to take home and there is also a prominent warning on the outside of the box.’
He also added that for some women valproate is the only option.
Dr Teo said: ‘Switching or discontinuing treatment before or during pregnancy carries the risk of recurrent seizures which could lead to brain damage or death.’