NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Valproate for epilepsy or bipolar disorder: Risk of abnormal pregnancy outcomes

The MHRA has published new information and strengthened warnings related to safety of medicines related to valproate (sodium valproate, valproic acid and valproate semisodium).

 

Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination with other medicines.

  • The risk of congenital malformations is approximately 10% compared to 2-3% in the general population
  • Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking, and/or walking, have low intellectual abilities, poor language skills and memory problems.
  • Children exposed to valproate in utero are at increased risk of autistic spectrum disorder and childhood autism. Limited data also suggests that they may be more likely to develop symptoms of attention deficit/hyperactivity disorder.

 

Given these risks, valproate for the treatment of epilepsy or bipolar disorder should not be used during pregnancy and in women of child-bearing potential unless other treatments are ineffective or not tolerated.

 

Valproate is now a black triangle medicine and is subject to additional monitoring. Any suspected side effects to valproate should be reported via the Yellow Card scheme.

 

More information can be found at: