European Medicines Agency Valporate Review
The European Medicine’s Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has as of March 2017, initiated a new review to examine the use of Valporate containing medicines in the treatment of women and girls who are pregnant or of child bearing age.
The PRAC will examine the available evidence and will consult with relevant stakeholder groups including a public hearing to listen directly to the experience of EU patients with these medicines so they can be taken into account as part of the Committee’s consideration.
Valporate containing medicines are approved nationally in Ireland in various presentations, under the brand name Epilim, to treat epilepsy and bipolar disorder. Valporate is also prescribed as a preventative medicine for migraine though it’s use for the treatment of migraine is unlicensed in Ireland.
WARNING: The Migraine Association of Ireland is aware that Sodium Volproate has been and is currently prescribed for chronic migraine sufferers in Ireland. Sodium Valproate does not have a licence for the treatment of migraine in Ireland. Prescription of this medicine for the treatment of migraine is therefore an off label or out of license usage. The manufacturers of Sodium Valproate, Sanofi, do not condone off label usage of any of their products. While Sanofi recognises that from time to time their medicines will be used in different ways out of license, this usage is a prerogative of the prescribing physician.
Children exposed in utero to Valporate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and or congenital malformations (approx 10% cases). They are also at an increased risk of autistic spectrum disorder (approx 3 fold) and childhood autism (5 fold). Limited data suggests they may be more likely to develop symptoms of ADHD also.
Valporate containing medicines should not be sued in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated.
Educational materials are available on the HPRA website
The HSE also has customised documents for use a as a local tool kit for prescribers and patients. Click here to access the toolkit.