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    Public Hearing focused on Sodium Valproate 26th September 2017 in London

    European Medicines Agency (EMA)

    Of all the hardships of life that can strike a family, having a child who suffers from malformations or is affected by developmental disorders that may be related to their mother's treatment with antiepileptic drugs is certainly one of the most painful. One can only be deeply touched by the distress of those who are so affected. Patient health is Sanofi's primary concern.

    The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) held its first public hearing, which focused on valproate and related substances, today, the 26th September 2017 at the Agency's premises in London.

    Valproate is a life-saving medicine commercialized since 1967. Valproate is listed as an essential medicine by the World Health Organization, which means that it must be available at all times for a functioning health system.

    Public hearings are a new tool allowing the EMA to engage with European Union (EU) citizens and relevant stakeholders (e.g. healthcare professionals, patients) in relation to the supervision of medicines and listen to their views and experiences. Public hearings are expected to give EU citizens a voice in the evaluation of the safety of medicines and empower them to express their views on questions related to the safety of specific medicines and the management of risks.

    The EU’s pharmacovigilance legislation enables the PRAC to hold public hearings during certain safety reviews of medicines. They support the committee's decision-making by providing perspective, knowledge and insights into the way medicines are used.

    Sanofi participated at the Public Hearing because we are the originator of valproate and we have actively contributed to the two European reviews of the use of valproate during pregnancy (the first one ended in Nov. 2014 and the current one). The Spokesperson was Dr Eric Teo, Sanofi’s Qualified Person for Pharmacovigilance in Europe.

    During the public hearing, Sanofi and all the participants addressed 3 questions:

    Question 1: What is your view of the risks of taking valproate during pregnancy, including its potential effect on the child?

    Question 2: What are your views on the measures currently in place to reduce the risks of using valproate during pregnancy?

    Question 3: What other measures should be taken to reduce the risks of using valproate during pregnancy?

    At the Public Hearing, Sanofi presented data on the risk minimization measures currently in place. Sanofi also put forward new proposals for discussion with the PRAC, patients and healthcare professionals.

    Sanofi reinforced the fact that Sodium Valproate is an important molecule that epileptic women continue to rely on, even today, to control seizures, to avoid a potentially fatal seizure during their lifetime, including during pregnancy.

    Doctors need a range of therapeutic options to help women with epilepsy through pregnancy. It is critical that both the risks of continuing treatment and the risks of stopping treatment are discussed before planning a pregnancy, bearing in mind that other medications also have risks.  It should be acknowledged that there is a real dilemma faced by physicians and women who have no other alternatives to control their seizure.

    Everyone in the healthcare system has a role to ensure that the risks as well as the benefits of valproate are understood.


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