Epilepsy drug (sodium valproate) leads to significantly increased risk of neuro-developmental disorders ( autism )

Children whose mothers take the antiepileptic drug sodium valproate while pregnant are at significantly increased risk of autism and other neurodevelopmental disorders, according to a new research published in the Journal of Neurology, Neurosurgery and Psychiatry.

What is Epilepsy?
Epilepsy is a brain disorder in which a person has repeated seizures (convulsions) over time. Seizures are episodes of disturbed brain activity that cause changes in attention or behavior.

What is Autism?
Autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills.

Study Details

The research involved kids born to 528 pregnant women in the north west of England between 2000 and 2004. Fifty percent (243) of the moms had epilepsy, only 34 of those women did not take antiepileptic drugs while pregnant.

Carbamazepine was taken by 59 of the women, valproate was taken by another 59 women, lamotrigine was taken by 36, forty-one of the females took a combination, and 15 took other medications.

The children's physical and intellectual development was assessed at the ages of 12 months, three and six years.

Findings

There were 415 kids who had complete data on all 3 evaluations. A neurodevelopmental disorder was diagnosed in 19 kids by the time they were 6 years old, three of those children were affected by a physical abnormality.

Twelve of these kids had a form of autism, one child also had ADHD (attention deficit hyperactivity disorder). Three had ADHD alone and another four had dyspraxia, a condition that results in poor physical co-ordination and excessive clumsiness.

Conclusion

According to study increase in risk of neurodevelopmental disorders in children exposed to monotherapy sodium valproate (VPA) (6/50, 12.0%; aOR 6.05, 95%CI 1.65 to 24.53, p=0.007) and in those exposed to polytherapy with sodium VPA (3/20, 15.0%; aOR 9.97, 95% CI 1.82 to 49.40, p=0.005) compared with control children (4/214; 1.87%). Autistic spectrum disorder was the most frequent diagnosis. No significant increase was found among children exposed to carbamazepine (1/50) or lamotrigine (2/30).It clearly mean children whose mothers had taken valproate singly or in combination with other drugs while pregnant were significantly more likely to have been diagnosed with a neurodevelopmental condition than those whose mothers were taking other drugs to treat their condition.

Children exposed to valproate alone during pregnancy were six times more likely to be diagnosed with a neurodevelopmental disorder.

Those exposed to valproate plus other drugs were 10 times more likely to do so than children whose mothers did not have the condition.

The women who had epilepsy and did not take drugs to treat the condition during pregnancy did not have any children diagnosed with a neurodevelopment disorder. However,  there was only a small number of females in this group.

The authors, from the Liverpool and Manchester Neurodevelopment Group, said other research had pointed to the potentially harmful effects of valproate on the developing foetus, and the findings of this study back other preliminary research.But further research would be needed before definitive conclusions could be reached.

They added: "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.But on no account should pregnant women just stop taking the drug for fear of harming their developing child."

Boys had a 3 times higher chance of being diagnosed with a nuerodevelopmental disorder. However, no notable links were identified for the mother's age or IQ, epileptic seizure type, or length of pregnancy.

Sanofi, the makers of anti-epilepsy medicine Epilim ( contains sodium valproate ) , 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."

The prevalence of neurodevelopmental disorders in children prenatally exposed to anti epileptic drugs
Rebecca Louise Bromley, George E Mawer, Maria Briggs, Christopher Cheyne, Jill Clayton-Smith, Marta García-Fiñana, Rachel Kneen, Sam B Lucas, Rebekah Shallcross, Gus A Baker
Journal of Neurology Neurosurgery and psychiatry 31 Jan, 2013; doi:10.1136/jnnp-2012-304270