We are aware of the difficult situations faced by families whose children present disorders that may be related to their mother's use of anti-epileptic drugs. The health of patients is Sanofi's primary concern. Preventing and treating the diseases that patients suffer from is at the heart of our mission.
Sodium valproate was first made available to physicians to treat patients suffering from epilepsy in the late 1960s. It was and still is one of the most effective treatments for epilepsy, a serious and complex disease that can be life-threatening. For some patients, this treatment is sometimes the only effective one, due to the lack of alternative therapies.
In the management of these patients, many healthcare professionals are involved. As a pharmaceutical company, our dual role is to :
- to make medicines available to patients,
- to provide both healthcare professionals and patients with information documents in line with the latest scientific knowledge and with approval of healthcare authorities.
As scientific knowledge of the risks associated with the use of sodium valproate has evolved, particularly during pregnancy, Sanofi has been transparent with the Health Authorities and has taken the initiative to request updates in the medical information intended for physicians and patients. Sanofi has systematically reminded patients, via the package insert, that they should consult their prescribing physician in the event of pregnancy or desire for pregnancy.
It should be remembered that drug companies cannot unilaterally decide to change the information documents relating to their medicines without the approval of the Health Authorities in each country where the product is marketed.
As part of its pharmacovigilance obligations, Sanofi continues to update information on its medicines for both healthcare professionals and patients, in line with developments in scientific knowledge and under the supervision of the Health Authorities.