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French regulator looking to ban epilepsy drug valproate

French regulator ANSM is considering a ban on epilepsy drug valproate for pregnant women or of child-bearing age.

Valproate is commonly used in children with generalized seizures who are prone to absence seizures and tonic-clonic seizures. It is also used for a variety of other seizures, in both children and adults, including tonic-clonic, myoclonic, complex partial, photosensitive, and the seizures associated with Juveninle Myoclonic Epilepsy (JME), Lennox-Gastaut syndrome and Dravet syndrome. It is known that valproate can cause birth defects, a reduced IQ, autism and other effects on brain development in children exposed to this drug in utero during pregnancy.

“Valproate is forbidden during pregnancy and should no longer be prescribed to girls, teenagers and women of child-bearing age unless exceptional circumstances,” France’s Agence Nationale de Securite du Medicament said in a statement.

Valproate is included in the World’s Health Organization list of essential medicines and is manufactured by French drugmaker Sanofi and sold under brands such as Depakine, Depakote and Epilim.

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