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    Information on Sodium Valproate (Depakine, Epilim)

    We are aware of the challenging situations faced by families with children with conditions that may be related to their mother's treatment with antiepileptic drugs. Patient health is Sanofi's primary concern. Preventing and treating the diseases suffered by patients is central to our mission.

    Sodium valproate was made available to physicians to treat epileptic patients in the 70’s. It was and still is one of the most effective treatments for epilepsy, a serious and complex disease that can be potentially fatal to patients. For some patients, sodium valproate is sometimes the only effective treatment due to the lack of a possible therapeutic alternative. For this reason, most health authorities in the world have not contraindicated it in women of childbearing age or in pregnant women in epilepsy.

    It should be kept in mind that the management of epilepsy in pregnant women or women of childbearing age is a particularly delicate and complex issue facing doctors and healthcare professionals. Indeed, the abrupt cessation of antiepileptic treatment can lead to the return of epileptic seizures that could put the life of the patient at risk (potential risk of sudden death), or even be detrimental to the development of the fetus. The choice of an antiepileptic treatment must be assessed by the physician on a case-by-case basis, taking into account the type of epilepsy and the benefits and risks of available treatments.

    Multiple health entities are involved in the care of patients. Our dual role, as a pharmaceutical company, is:

    • making medicines available to patients,
    • Providing both health professionals and patients, under the oversight of the Health Authority, information documents in line with the state of scientific knowledge and regulations.

    As scientific knowledge about the risks associated with the use of sodium valproate has increased, particularly during pregnancy, Sanofi has demonstrated full transparency to health authorities and initiated the updating of medical information for doctors and patients. Sanofi has systematically reminded patients via the information document that they should consult their prescribing physician in case of pregnancy or desire for pregnancy so that their physician can act accordingly.

    From the beginning of the 1980s, we have provided information about the risk of malformations of the fetus. In the early 2000s, on the basis of new scientific data, we repeatedly sought the advice of health authorities on questions raised by some scientists concerning the occurrence of neurodevelopmental delays in children exposed in utero to sodium valproate. Sanofi also proposed changes to the product information documents.

    It should be underline that pharmaceutical companies cannot / could not unilaterally decide to change the information documents relating to their medicines without the approval of the health authorities of each country where the product is marketed.

    As part of its pharmacovigilance obligations, Sanofi continues to update, as scientific knowledge evolves and under the oversight of health authorities, information on its medicines, intended both for healthcare professionals and patients.

    At Sanofi, patient safety is our primary concern and preventing and treating patient diseases is at the heart of our mission.

     

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