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Autism risk of drug taken by thousands of mums for epilepsy: Up to 17,500 children affected since 1973, researchers believeAs many as one in three children born to mothers taking Epilim affectedDrug taken by about 21,500 women of childbearing age to control seizuresFamilies campaigning for manufacturer to withdraw the drug
00:54 GMT, 4 February 2013
08:05 GMT, 4 February 2013
Dangers: Researchers have warned as many as one in three children born to mothers taking Epilim have developed autism or behavioural problems (file picture)
An epilepsy drug taken by thousands of women has been linked to learning disabilities in children.
Researchers say as many as one in three children born to mothers taking Epilim have developed autism or behavioural problems.
They believe up to 17,500 children in Britain have been affected since 1973, when it was launched.
Families campaigning for the manufacturer Sanofi to withdraw the drug are to meet Labour health spokesman Andy Burnham this week to enlist his support.
Around 21,500 women of childbearing age take Epilim in the UK every year to control or prevent seizures. It is one of the registered trade names for sodium valproate, which affects electrical activity in the brain.
But doctors have known for some time that the drug may cause developmental problems or deformities in babies.
In Saturday’s Mail, writer Carol Sarler told how it had left her three-year-old granddaughter so profoundly brain damaged she could barely speak. Milly is due to start school next year but cannot even say her name, let alone read.
Her mother Flynn was prescribed the drug for epilepsy and the family are convinced it affected Milly’s brain while she was in the womb.
Academics at Liverpool University estimate that 35 per cent of the 48,000 to 50,000 women who have taken it since it came on the market have been affected.
Their research, monitoring the development over six years of 243 babies born to mothers with epilepsy between 2000 and 2004, including 59 taking Epilim, is published in the Journal of Neurology, Neurosurgery and Psychiatry.
Rebecca Bromley, a senior neuro-psychologist at Liverpool University who led the study, said: ‘If sodium valproate is the treatment of choice, women should be provided with as much information as possible to enable them to make an informed decision.
Research: Scientists believe up to 17,500 children in Britain have been affected since 1973, when the drug was launched
‘But on no account should pregnant women just stop taking it for fear of harming their developing child.’
GPs have been advised for some time not to prescribe the drug to pregnant women due to the risks, but it is difficult for those already taking it to stop as the resulting seizures can also harm the baby.
A spokesman for Sanofi said: ‘For some women of child-bearing potential, valproate may be the only effective seizure control medication; however, a decision to use valproate in women of child-bearing potential should only be taken after a very careful evaluation, between the patient and her treating physician, if the benefits of its use outweigh the risks to the unborn child.
‘This decision is to be taken before valproate is prescribed for the first time as well as before a woman already treated with valproate is planning a pregnancy.’
Medication: Academics at Liverpool University estimate 35 per cent of the 48,000 to 50,000 women who have taken it since it came on the market have been affected