Medicines containing valproate, the best known brand being Epilim®, are used for the treatment of epilepsy and other conditions.
It has long been known that if taken during pregnancy such medicines can affect the unborn child. Reports suggest a 10% risk of physical abnormalities and a 40% risk of mental disabilities with the BBC reporting that some 20,000 babies may have been affected in the UK since the drugs launch some 40 years ago. However for some patients valproate may be the only treatment option. In all, it is probably taken by 200,000 people in the UK although the manufacturers say it is no longer recommended as a first choice epilepsy treatment for women of childbearing age
Manufacturers have long given warnings to doctors and on patient leaflets of these risks and as recently as 2014 the warnings and restrictions were strengthened following a previous review. That review also recommended further studies at EU level to measure the effectiveness of the warnings.
Consequently several EU member states carried out assessments resulting in concerns as to how effective the measures have been in increasing awareness. The French medicines regulator asked the EMA to look again at ways of reducing the risks in women who are pregnant or of childbearing age. This new review began in March 2017 and the EMA felt it was important to have a public hearing, its first ever, to take into account the views and experiences of patients, affected families and others. The EMA will now continue its assessment and will then publish a report with recommendations on the safer use of such medicines.