Britain bans Sanofi’s controversial epilepsy drug causing developmental disorders in the babies at the wombs. The valproate drugs are able to cut the risk of seizures, but the regulations over the medicines have now been changed as the new study has found women using these drugs with higher chances of delivering babies with developmental disorders or birth defects.
The drug manufactured by the French multinational pharmaceutical company – Sanofi, was used with a brand – Depakote and Depamide over treating bipolar disorder and Depakine to treat epilepsy, while the drug is now recalled in Britain to be used by females of child-bearing age over being a contributor for the birth defects in unborn child. The drug will remain banned unless the company provides certain pregnancy prevention program.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has taken this action due to the insufficient information offered to patients regarding the negative impacts of valproate that France approved in 1967 for the first time and later, was widely used to treat epilepsy.
“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy,” said Dr June Raine, Director of Vigilance Risk Management of Medicines at the MHRA. “However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.”
“We know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy,” said deputy chief executive for Epilepsy Action, Simon Wigglesworth.