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Epilepsy drug linked to 4,000 birth defects in France

French regulator says women taking the drug were four times more likely to have babies with malformations

Ingrid Torjesen

Friday, 21 April 2017

The epilepsy drug valproate has been responsible for up to 4,100 “severe malformations” in children in France since it was launched in 1967, according to a preliminary study by French health authorities.

Women who took the drug during pregnancy to treat epilepsy were four times more likely to give birth to babies with congenital malformations, says a report of the study’s findings, issued by the medicines regulator ANSM and the national health insurance administration.

The report estimates that 2,150 and 4,100 babies were born with severe malformations. These malformations included spina bifida, and defects of the heart and genital organs. The risk of autism and developmental problems was also found to be higher.

From 1967 to 2016, between 64,100 and 100,000 pregnancies in France were exposed to valproate, resulting in 41,200 to 75,300 live births, according to the report.

The vast majority of the birth defects occurred for women under treatment for epilepsy, from the late 1970s, valproate was also prescribed in France to treat bipolar disorder.

Bipolar women taking the drug were twice as likely to give birth to children with major birth defects, the study found. The risk is believed to be lower, compared with women treated for epilepsy, because doctors are more likely to have stopped prescribing the drug to pregnant bipolar women early in the pregnancy.

The risk of birth defects associated with valproate has been known since the 1980s, but the drug can still be prescribed to pregnant women when all other forms of treatment for epilepsy fail.

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