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Study provides reassurance for pregnant women who take levetiracetam

Women with epilepsy who take levetiracetam during pregnancy can be reassured that the medicine does not seem to impair their child’s future cognitive or motor skills, according to a study published in Neurology (online 8 January 2014). However, concerns over the use of valproate during pregnancy remain.

Furthermore, the influence of seizure frequency, type and severity during pregnancy — which were not recorded in the study — was questioned in an accompanying commentary to the study.

The authors of the commentary draw attention to clinical guidance: “If seizures can be controlled without substantial side effects by one of the antiepileptic drugs for which pregnancy outcome and neurodevelopmental data appear superior to valproate, ie, lamotrigine, carbamazepine and levetiracetam, those [medicines] should be used in preference to valproate.”

However, they add that for women whose seizures do not respond to the alternative antiepileptic medicines, but which do respond to valproate, the decision is more difficult. More research is needed to establish the contribution that seizures make to pregnancy outcomes in these women, as opposed to the contribution from antiepileptic drugs, they say.

In the study, researchers recruited children aged between 36 and 54 months, using the UK Epilepsy and Pregnancy Register. Children in the control group were born to mothers without epilepsy and who were not exposed to medicines.

Mental development and language skills were comparable between children who were exposed to levetiracetam and the control group. However, children exposed to valproate had significantly poorer mental development and language skills compared with the control and levetiracetam groups (see Panel).  

Additionally, women who reported having seizures during pregnancy were found to have children with significantly poorer developmental outcomes (frequency, type and severity of seizures were not recorded, see panel).

The researchers report no difference in outcomes associated with the dose of medication during pregnancy. However, the commentator in the editorial notes that a dose effect has been observed with these medicines in other studies.

Study results

Children born to women with epilepsy who took sodium valproate during pregnancy (n=44) scored an average 15.8 points lower on the Griffiths Mental Development Scale for gross motor skills than children who were exposed to levetiracetam (n=53; P<0.001). But there was no difference in social, hand and eye or non-verbal performance skills between the levetiracetam and valproate groups.

On the Reynell Developmental Language Scales, children in the valproate group scored 6.4 points below children exposed to levetiracetam for comprehension language abilities and 9.5 points below for expressive language abilities (P=0.005 and P<0.001, respectively). There was no difference between the abilities of the children who were exposed to levetiracetam and the control group children (n=131).

Maternal reporting of at least one seizure during pregnancy was predictive of poorer developmental outcomes for the child. This was true of gross motor skills (-19.2, P<0.001), personal and social skills (-12.2, P=0.002), hand and eye co-ordination skills(-11.4, P<0.001), performance skills (-12.9, P<0.001) and comprehensive language abilities (-7.6, P=0.002).

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11132681

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