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EMA Urged To Do Better On Valproate Risk Reduction In Pregnant Women

There were passionate testimonies from patients affected by Sanofi’s anti-epileptic drug valproate at the European Medicines Agency's first public hearing on medicines safety. There was almost full agreement among those who testified that existing risk reduction measures are not working.

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EMA Says It Has Gained Enormously From The First Public Hearing • Source: Shutterstock

At the European Medicines Agency's first ever public hearing on the safety of marketed medicines, patients gave personal and sometimes emotional accounts of how existing measures to minimize the harmful effects in pregnant women of Sanofi's anti-epileptic drug, valproate, had in some cases failed miserably, resulting in thousands of children being born with developmental disorders.

These failings are still happening as a result of variations in how the drug is prescribed and dispensed across EU member states, patients said

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