Document Detail


Levetiracetam in pregnancy: results from the UK and Ireland epilepsy and pregnancy registers.
MedLine Citation:
PMID:  23303847     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Levetiracetam is a broad-spectrum antiepileptic drug (AED) which is currently licensed in the United States and the United Kingdom and Ireland for use as adjunctive treatment of focal-onset seizures and myoclonic seizures or generalized tonic-clonic seizures, occurring as part of generalized epilepsy syndromes. In the United Kingdom and Ireland, it is also licensed as monotherapy treatment for focal-onset seizures. Previous small studies have suggested a low risk for major congenital malformations (MCM) with levetiracetam use in pregnancy.
METHODS: The UK and Ireland Epilepsy and Pregnancy Registers are prospective, observational registration and follow-up studies that were set up to determine the relative safety of all AEDs taken in pregnancy. Here we report our combined results for first-trimester exposures to levetiracetam from October 2000 to August 2011.
RESULTS: Outcome data were available for 671 pregnancies. Of these, 304 had been exposed to levetiracetam in monotherapy, and 367 had been exposed to levetiracetam in combination with at least one other AED. There were 2 MCM in the monotherapy group (0.70%; 95% confidence interval [CI] 0.19%-2.51%) and 19 in the polytherapy group 5.56% (3.54%–8.56%) [corrected]. The MCM rate in the polytherapy group varied by AED regimen, with lower rates when levetiracetam was given with lamotrigine (1.77%; 95% CI 0.49%-6.22%) than when given with valproate (6.90%; 95% CI 1.91%-21.96%) or carbamazepine (9.38%; 95% CI 4.37%-18.98%).
CONCLUSION: This study, in a meaningful number of exposed pregnancies, confirms a low risk for MCM with levetiracetam monotherapy use in pregnancy. MCM risk is higher when levetiracetam is taken as part of a polytherapy regimen, although further work is required to determine the risks of particular combinations. With respect to MCM, levetiracetam taken in monotherapy can be considered a safer alternative to valproate for women with epilepsy of childbearing age.
Authors:
Ellen Mawhinney; John Craig; Jim Morrow; Aline Russell; W Henry Smithson; Linda Parsons; Patrick J Morrison; Brenda Liggan; Beth Irwin; Norman Delanty; Stephen J Hunt
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Publication Detail:
Type:  Journal Article     Date:  2013-01-09
Journal Detail:
Title:  Neurology     Volume:  80     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-22     Completed Date:  2013-03-19     Revised Date:  2013-03-26    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  400-5     Citation Subset:  AIM; IM    
Affiliation:
Neurology Department, Belfast Health and Social Care Trust, Royal Victoria Hospital, Belfast, Ireland.
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology*
Adult
Anticonvulsants / administration & dosage,  adverse effects
Drug Therapy, Combination / adverse effects
Epilepsy, Generalized / drug therapy*,  epidemiology
Epilepsy, Tonic-Clonic / drug therapy*,  epidemiology
Female
Follow-Up Studies
Great Britain / epidemiology
Humans
Infant, Newborn
Ireland / epidemiology
Male
Piracetam / administration & dosage,  adverse effects,  analogs & derivatives*
Pregnancy
Pregnancy Complications / chemically induced*,  epidemiology
Pregnancy Trimester, First / drug effects
Registries / statistics & numerical data
Risk Factors
Valproic Acid / administration & dosage,  adverse effects
Chemical
Reg. No./Substance:
0/Anticonvulsants; 230447L0GL/etiracetam; 7491-74-9/Piracetam; 99-66-1/Valproic Acid
Comments/Corrections
Erratum In:
Neurology. 2013 Feb 12;80(7):691

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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