Valproate and the risk for congenital malformations; is formulation and dosage regime important?

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dc.contributor.author Campbell, J.
dc.contributor.author Craig, John J.
dc.contributor.author Russell, A.
dc.contributor.author Smithson, W. Henry
dc.contributor.author Parsons, L.
dc.contributor.author Morrison, P. J.
dc.contributor.author Liggan, B.
dc.contributor.author Irwin, B.
dc.contributor.author Delanty, Norman
dc.contributor.author Hunt, S. J.
dc.contributor.author Morrow, J.
dc.contributor.author Mawhinney, E.
dc.date.accessioned 2018-10-08T10:25:01Z
dc.date.available 2018-10-08T10:25:01Z
dc.date.issued 2012-04
dc.identifier.citation Mawhinney, E., Campbell, J., Craig, J., Russell, A., Smithson, W. Henry, Parsons, L., Morrison, P. J., Liggan, B., Irwin, B., Delanty, N., Hunt, S. J. and Morrow, J. (2012) 'Valproate and the risk for congenital malformations; is formulation and dosage regime important?', Seizure - European Journal of Epilepsy, 21(3), pp. 215-218. doi:10.1016/j.seizure.2012.01.005 en
dc.identifier.volume 21 en
dc.identifier.issued 3 en
dc.identifier.startpage 215 en
dc.identifier.endpage 218 en
dc.identifier.issn 1059-1311
dc.identifier.uri http://hdl.handle.net/10468/6989
dc.identifier.doi 10.1016/j.seizure.2012.01.005
dc.description.abstract Background: Use of valproate in pregnancy, especially in doses over 1000 mg a day, is known to be associated with a higher risk for major congenital malformations compared with other antiepileptic drugs. We sought to investigate whether the increased risk could be minimised by using controlled release or divided daily doses of valproate. Methods: The UK Epilepsy and Pregnancy Register is a prospective, observational and follow up study set up to determine the risks of major congenital malformations for infants exposed to antiepileptic drugs in utero. In this study we have extracted data for those pregnancies exposed to valproate in monotherapy. We have calculated malformation rates and relative risks as a function of valproate exposure. Results: Outcome data were available for 1109 pregnancies exposed to valproate in monotherapy. Exposure to 1000 mg a day or more of valproate was associated with almost double the risk of major congenital malformation compared with daily valproate doses below 1000 mg daily (8.86% vs 4.88%, RR: 1.7; 95% CI: 1.1â 2.9). There were no differences in the risks for malformations between standard release valproate and controlled release valproate preparations (RR: 1.11; 95% CI: 0.67â 1.83) or for those exposed to single or multiple daily administrations (RR: 0.99, 95% CI: 0.58â 1.70). Conclusion: Prescribing controlled release valproate or multiple daily administrations in pregnancy did not reduce the risk for malformations. Higher malformation rates observed with in utero exposure to valproate are more likely related to total daily dose, rather than peak serum levels. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier B.V. en
dc.rights © 2012, British Epilepsy Association. Published by Elsevier Ltd. Open access under CC BY-NC-ND license. en
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/3.0/ en
dc.subject Epilepsy en
dc.subject Pregnancy en
dc.subject Antiepileptic drugs en
dc.subject Valproate en
dc.subject Major congenital malformations en
dc.title Valproate and the risk for congenital malformations; is formulation and dosage regime important? en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother William Henry Smithson, General Practice, University College Cork, Cork, Ireland. +353-21-490-3000 Email: henry.smithson@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2018-10-08T10:11:42Z
dc.description.version Published Version en
dc.internal.rssid 250594456
dc.description.status Peer reviewed en
dc.identifier.journaltitle Seizure -European Journal of Epilepsy en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress henry.smithson@ucc.ie en


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© 2012, British Epilepsy Association. Published by Elsevier Ltd. Open access under CC BY-NC-ND license. Except where otherwise noted, this item's license is described as © 2012, British Epilepsy Association. Published by Elsevier Ltd. Open access under CC BY-NC-ND license.
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