EMA to review risk of valproate in pregnancy

A review into the effects of valproate on pregnant women is being carried out by the European Medicines Agency (EMA).

The treatment has been used throughout the EU for almost half a century to address conditions including epilepsy and bipolar disorder, while it is also used to prevent migraines.

However, the EMA has acknowledged that uncertainties about exactly how it works still remain, with one possibility being that it boosts the amount of the gamma-aminobutyric acid neurotransmitter and therefore functions as a mood stabiliser.

Another theory is that the medicine prevents electrically charged sodium particles passing through miniscule pores on the surface of cells, which means excessive electrical activity in the brain is reduced.

The organisation also pointed out that it has been established for some time that if pregnant women take anti-epileptic medicines, the risk of their children experiencing birth defects could be increased.

As a result, the EMA wants to find out whether or not valproate medicines could be associated with a greater risk of birth defects than alternative antiepileptic treatments.

“It has also been known that development may be delayed in children born to women who were treated with valproate medicines during pregnancy,” the group said.

The EMA went on to stress that information on the use of valproate medicines during pregnancy is available on product information throughout the EU.

Nevertheless, it said the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has expressed concern that these details have not been brought into line with the latest scientific evidence and therefore might not be fit for purpose.

The EMA has therefore pledged to “review the available data on the benefits and risks of valproate and related substances and issue an opinion on the use of these medicines in pregnant women”.

Many names for valproate and related medicines are currently used throughout the EU, including Absenor, Delepsine, Depaknine, Hexaquin, Orfiril and Valhel, along with Convival Chrono, Convulsofin Tabletten, Diplexil, Epilim and Episenta.

Posted by Steve Long

News categories