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Published online before print April 27, 2009, doi:10.1212/WNL.0b013e3181a6b325)
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NEUROLOGY 2009;73:142-149
© 2009 American Academy of Neurology
Special Article

Practice Parameter update: Management issues for women with epilepsy—Focus on pregnancy (an evidence-based review): Vitamin K, folic acid, blood levels, and breastfeeding

Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society

C. L. Harden, MD, P. B. Pennell, MD, B. S. Koppel, MD, C. A. Hovinga, PharmD, B. Gidal, PharmD, K. J. Meador, MD, J. Hopp, MD, T. Y. Ting, MD, W. A. Hauser, MD, D. Thurman, MD, MPH, P. W. Kaplan, MB, FRCP, J. N. Robinson, MD, J. A. French, MD, S. Wiebe, MD, A. N. Wilner, MD, B. Vazquez, MD, L. Holmes, MD, A. Krumholz, MD, R. Finnell, PhD, P. O. Shafer, RN, MN and C. Le Guen

Authors’ affiliations are listed at the end of the article.
From the University of Miami (C.L.H.), Miami, FL; Emory University (P.B.P., K.J.M.), Atlanta, GA; New York Medical College (B.S.K.), New York; University of Tennessee Health Science Center (C.A.H.), Memphis; University of Wisconsin–Madison School of Pharmacy (B.G.); University of Maryland (J.H., T.Y.T., A.K.), Baltimore; Columbia University (W.A.H.), New York, NY; Centers for Disease Control and Prevention (D.T.), Atlanta, GA; Johns Hopkins University (P.W.K.), Baltimore, MD; Harvard Medical School (J.N.R., L.H.), Boston, MA; New York University School of Medicine (J.A.F.), New York; University of Calgary (S.W.), Alberta, Canada; private practice (A.N.W.), Newport, RI; New York University (B.V.), New York; Texas A&M University Health Science Center (R.F.), Houston; Beth Israel Deaconess Medical Center (P.O.S.), Boston, MA; and University of Pennsylvania (C.L.), Philadelphia.

Address correspondence and reprint requests to the American Academy of Neurology, 1080 Montreal Avenue, St. Paul, MN 55116 guidelines{at}aan.com

Objective: To reassess the evidence for management issues related to the care of women with epilepsy (WWE) during pregnancy, including preconceptional folic acid use, prenatal vitamin K use, risk of hemorrhagic disease of the newborn, clinical implications of placental and breast milk transfer of antiepileptic drugs (AEDs), risks of breastfeeding, and change in AED levels during pregnancy.

Methods: A 20-member committee evaluated the available evidence based on a structured literature review and classification of relevant articles published between 1985 and October 2007.

Results: Preconceptional folic acid supplementation is possibly effective in preventing major congenital malformations in the newborns of WWE taking AEDs. There is inadequate evidence to determine if the newborns of WWE taking AEDs have a substantially increased risk of hemorrhagic complications. Primidone and levetiracetam probably transfer into breast milk in amounts that may be clinically important. Valproate, phenobarbital, phenytoin, and carbamazepine probably are not transferred into breast milk in clinically important amounts. Pregnancy probably causes an increase in the clearance and a decrease in the concentration of lamotrigine, phenytoin, and to a lesser extent carbamazepine, and possibly decreases the level of levetiracetam and the active oxcarbazepine metabolite, the monohydroxy derivative.

Recommendations: Supplementing women with epilepsy with at least 0.4 mg of folic acid before they become pregnant may be considered (Level C). Monitoring of lamotrigine, carbamazepine, and phenytoin levels during pregnancy should be considered (Level B) and monitoring of levetiracetam and oxcarbazepine (as monohydroxy derivative) levels may be considered (Level C). A paucity of evidence limited the strength of many recommendations.

Abbreviations: AAN = American Academy of Neurology; AED = antiepileptic drug; CBZ = carbamazepine; CI = confidence interval; ESM = ethosuximide; GBP = gabapentin; LTG = lamotrigine; LVT = levetiracetam; MHD = monohydroxy derivative; OR = odds ratio; OXC = oxcarbazepine; PB = phenobarbital; PHT = phenytoin; PRM = primidone; TPM = topiramate; VPA = valproate; WWE = women with epilepsy.

Supplemental data at www.neurology.org

See pages 126 and 133

e-Pub ahead of print on April 27, 2009, at www.neurology.org.

Published simultaneously in Epilepsia.

The Mission Statements of the Quality Standards Subcommittee (QSS) and Therapeutics and Technology Assessment (TTA) Subcommittee, Conflict of Interest Statement, QSS members, TTA members, AAN classification of evidence, Classification of recommendations (appendices e-1 through e-5), as well as references e1 through e5 and tables e-1 through e-8, are available on the Neurology® Web site at www.neurology.org.

Approved by the Quality Standards Subcommittee April 15, 2008; by the Therapeutics and Technology Assessment Subcommittee December 17, 2007; by the Practice Committee January 10, 2009; and by the AAN Board of Directors March 25, 2009.

Supported by The Milken Family Foundation.

Disclosure: Author disclosures are provided at the end of the article.

Received January 13, 2009. Accepted in final form March 23, 2009.


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