We are aware of the difficult situations faced by families whose children present disorders that may be related to their mother's use of medical treatment. 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 or from bipolar disorders since the late 1960s. Today, it remains one of the most effective treatments for epilepsy, a serious and complex medical condition that can be life-threatening. For some of these patients, this treatment is sometimes the only effective one, due to the lack of alternative therapies.
Many healthcare professionals are involved in patient care. As a pharmaceutical company, our 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 approved by health authorities.
As scientific knowledge of the risks associated with the use of sodium valproate has evolved 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 female patients, via the package insert, that they should consult their prescribing physician in the event of pregnancy or desire for pregnancy.
Since the early 1980s, we have been informing about the risk of fetal malformations. These warnings were updated as the scientific knowledge evolved overtime. And since the early 2000s, on the basis of the new scientific data available, we have repeatedly alerted the health authorities to the risks of neurodevelopmental delays in children exposed in utero to sodium valproate, and consequently requested changes to product labelling.
When new scientific data emerged first suggesting, then confirming, that some children born to mothers who had taken valproate during pregnancy could suffer from neurodevelopmental disorders, this too was passed on to the health authorities for assessment. Sanofi has forwarded this information to the health authorities and made it available to prescribers and patients in product labelling and educational materials, once they have been approved by the health authorities.
More recently, new scientific data have emerged, suggesting a potential risk of neurodevelopmental disorders in children born to fathers who took valproate in the three months prior to conception, which Sanofi has also passed on to the health authorities. As a precautionary measure, this information is made available to prescribers and patients in product labelling and supplementary educational materials, once approved by the health authorities.
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.