UK MCA may tighten warnings on valproate

The UK Medicines Control Agency has said that it may issue new advice onthe possible risks associated with the use of the epilepsy drug sodium valproate in pregnancy, in the wake of a number of published surveys which, says the agency, have pointed to an increase in congenital malformations born to women with epilepsy.

Sodium valproate is sold in the UK as Epilim by Sanofi-Synthelabo and a number of generic manufacturers, and has been a mainstay of epilepsy treatment for decades. While other anticonvulsant medications are also associated with an increased risk of birth defects, an MCA statement points to recent evidence that the risk with valproate may be twice that of other epilepsy drugs. However, the agency cautions that it is difficult to establish whether the disease itself (eg as a result of fetal hypoxia during fitting), or the medications used to treat it, are responsible for the increased malformation rate.

Valproate labeling already carries a warning indicating that it should only be used in women of childbearing age in cases of severe epilepsy and where the patient is resistant to treatment with other drugs.