Warning over epilepsy drug dubbed ‘new thalidomide’
THOUSANDS of British mothersto-be are taking an epilepsy drug dubbed ‘the new thalidomide’ because of its link to birth defects, despite decades of health warnings, say campaigners.
Last year the Department of Health and prescribing watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) issued new guidance that every woman of child-bearing age given the seizure-controlling medication, sodium valproate, should be warned of the risks.
Yet according to new research, one in five of those on the drug were unaware of the damage it can cause to an unborn foetus.
Up to 40 per cent of children exposed to sodium valproate in the womb had developmental problems, including delayed walking, speech, memory and language skills.
In 2013, researchers found that of the 48,000 children born to mothers in the UK who have taken the drug since it was introduced in 1973, 19,200 have developed physical or mental problems.
This is a far greater number than those affected in the thalidomide scandal of the 1960s – when about 2,000 babies were born with missing or shortened limbs after their mothers took the drug thalidomide to control morning sickness.
UK charities Young Epilepsy, Epilepsy Action and the Epilepsy Society interviewed 3,000 women with the incurable brain condition for the new research, which found that half of all those questioned – whether or not they were on the drug – were unaware of the potential problems.
The drug, also known by brand names Epilim, Convulex, Episenta and Epival, controls electrical functions in the brain to halt seizures, and has also been linked to defects including spina bifida and facial abnormalities.
In addition, it increases the risk of childhood autism.
Latest figures, based on NHS prescriptions dispensed, show that more than 21,000 women are currently on the drug, with an estimated 177 babies a year born with sodium valproate syndrome.
Lisa Horton, 36, has been on Epilim since she was a teenager. She was on a low dose when she had eldest son Josh, 17, and he was born unaffected by his mother’s medication.
But by the time her second child, Kieran, now five, was born, she was on a high dose of the drug to control her seizures.
The nursery nurse from Coxhoe, County Durham, said: ‘He was born with a cleft palate and hypertonia, which caused him to be floppy as a baby.
‘Although physiotherapy has helped, he has walking and balance problems, has difficulty swallowing and digesting food, and has difficulty with speech and language and needs visual aids at school, where he is at least a year behind classmates.
‘He also has a narrowed and thin windpipe, which made it hard for him to breathe, especially when he was asleep, and he has had to have his tonsils and adenoids removed to help with that.’
Lisa is adamant that no doctor informed her about the risks of sodium valproate in pregnancy.
She added: ‘The first time I realised Kieran must have been affected was when I saw a Panorama documentary on my drug in 2013.’
Emma Murphy, a 32-year-old Manchester-based mother with epilepsy, and a founder of the Independent Fetal Anti-Convulsant Trust (In-FACT), said: ‘This is the new thalidomide – in fact it is bigger. It’s not just epileptic mothers whose babies are harmed. Sodium valproate is also given to women with bipolar disorder and severe migraine.
‘Women must be told by doctors before they start a family that there is a danger in using this drug when they are expecting.’
Ms Murphy and her In-FACT co-founder Janet Williams believe that despite changes in the guidance, it is taking too long for information to reach women.
Ms Murphy said: ‘We have investigated why it hasn’t been filtering down and we believe that had NHS England been involved in this alongside the MHRA – which they have not – then GPs would have been given this information straight away in April this year.’
Professor Ley Sander, a neurologist who treats epilepsy at University College London Hospitals, said: ‘These figures highlight a pressing need for women with epilepsy to have the right information about all aspects of pregnancy and the risks linked with sodium valproate.
‘Our problem is that it is a very effective drug for epilepsy, and for some it is the only one that will control their seizures.
‘If a woman is on sodium valproate and becomes pregnant, we cannot take her off the drug as this can put the lives of mothers and babies at risk from a seizure.
‘It is crucial that women do not stop taking their epilepsy medication without talking to a healthcare professional beforehand, and preconception counselling is essential.’