CSM updates its advice on the use of sodium valproate in pregnancy
Women who could become pregnant should not be started on sodium valproate without specialist neurological advice, the Committee on Safety of Medicines has advised.
Sodium valproate is known to be associated with an increased incidence
of congenital malformations and two retrospective studies have suggested
a link between in utero exposure and developmental delay.
The recommendation, which is published in the September issue of Current
Problems in Pharmacovigilance, comes following a review of published
data by the CSM. The review was sparked by a campaign in The Times, which
highlighted the cases of a number of women who thought they had not been
properly warned about the risks associated with the drug (PJ, 2 February
2002, p125).
The CSM points out that sodium valproate is the drug of choice in patients
with certain types of epilepsy and advises that if it is prescribed during
pregnancy, it should be given as monotherapy at the lowest effective
dose and in divided doses. In addition,
prolonged-release preparations should be used where possible. The CSM
also recommends that women who want to become pregnant and who decide
to continue sodium valproate treatment should be advised to take 5mg
folic acid as soon as contraception is discontinued.
The summary of product characteristics for Epilim was updated to reflect
the new advice in June (PJ, 28 June, p885). |
