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Focus on Pregnancy: Vitamin K, Folic Acid 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, P. B. Pennell, B. S. Koppel, et al. Neurology 2009;73;142-149 Published Online before print April 27, 2009 DOI 10.1212/WNL.0b013e3181a6b325 This information is current as of April 27, 2009 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.neurology.org/content/73/2/142.full.html Neurology ® is the official journal of the American Academy of Neurology. Published continuously since 1951, it is now a weekly with 48 issues per year. Copyright . All rights reserved. Print ISSN: 0028-3878. Online ISSN: 1526-632X. 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 ABSTRACT P.B. Pennell, MD Objective: To reassess the evidence for management issues related to the care of women with B.S. Koppel, MD epilepsy (WWE) during pregnancy, including preconceptional folic acid use, prenatal vitamin K C.A. Hovinga, PharmD use, risk of hemorrhagic disease of the newborn, clinical implications of placental and breast B. Gidal, PharmD milk transfer of antiepileptic drugs (AEDs), risks of breastfeeding, and change in AED levels K.J. Meador, MD during pregnancy. J. Hopp, MD Methods: A 20-member committee evaluated the available evidence based on a structured litera- T.Y. Ting, MD ture review and classification of relevant articles published between 1985 and October 2007. W.A. Hauser, MD D. Thurman, MD, MPH Results: Preconceptional folic acid supplementation is possibly effective in preventing major P.W. Kaplan, MB, FRCP congenital malformations in the newborns of WWE taking AEDs. There is inadequate evidence J.N. Robinson, MD to determine if the newborns of WWE taking AEDs have a substantially increased risk of J.A. French, MD hemorrhagic complications. Primidone and levetiracetam probably transfer into breast milk in S. Wiebe, MD amounts that may be clinically important. Valproate, phenobarbital, phenytoin, and carbamaz- A.N. Wilner, MD epine probably are not transferred into breast milk in clinically important amounts. Pregnancy B. Vazquez, MD probably causes an increase in the clearance and a decrease in the concentration of lam- L. Holmes, MD otrigine, phenytoin, and to a lesser extent carbamazepine, and possibly decreases the level of A. Krumholz, MD levetiracetam and the active oxcarbazepine metabolite, the monohydroxy derivative. R. Finnell, PhD Recommendations: Supplementing women with epilepsy with at least 0.4 mg of folic acid be- P.O. Shafer, RN, MN fore they become pregnant may be considered (Level C). Monitoring of lamotrigine, carbamazepine, C. Le Guen 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. Neurology® 2009;73:142–149 Address correspondence and reprint requests to the American Academy of Neurology, 1080 GLOSSARY Montreal Avenue, St. Paul, MN AAN ϭ American Academy of Neurology; AED ϭ antiepileptic drug; CBZ ϭ carbamazepine; CI ϭ confidence interval; ESM ϭ 55116 ethosuximide; GBP ϭ gabapentin; LTG ϭ lamotrigine; LVT ϭ levetiracetam; MHD ϭ monohydroxy derivative; OR ϭ odds ratio; [email protected] OXC ϭ oxcarbazepine; PB ϭ phenobarbital; PHT ϭ phenytoin; PRM ϭ primidone; TPM ϭ topiramate; VPA ϭ valproate; WWE ϭ women with epilepsy. Recent estimates of the US population1 and the prev- voked seizures, and the treatment is typically a daily, alence of epilepsy2 indicate that approximately one- long-term antiepileptic drug (AED) regimen. The half million women with epilepsy (WWE) are of majority of people with epilepsy have well-controlled childbearing age. It has also been estimated that three seizures, are otherwise healthy, and therefore expect to five births per thousand will be to WWE.3 Epi- to participate fully in life experiences, including lepsy is defined by the presence of recurrent, unpro- childbearing. 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. Authors’ affiliations are listed at the end of the article. 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. 142 Copyright © 2009 by AAN Enterprises, Inc. This parameter summarizes evidence for six im- ciently sensitive to exclude a substantial risk portant questions relating to the clinical manage- reduction from folic acid supplementation. One ment of WWE who are pregnant or plan pregnancy: study reported an OR of 1.67 for MCMs in the off- spring of mothers on valproate (VPA) who were not 1. Does preconceptional folic acid supplementation taking folic acid supplementation. However, the re- reduce the risk of birth defects in neonates of sult was not significant (95% CI 0.62–4.50).8 bxAn- WWE taking AEDs? other study showed no effect of folic acid 2. What is the risk of hemorrhagic disease in neo- supplementation (OR 0.86, 95% CI 0.34–2.15),9 nates born to WWE taking AEDs? but lacked the statistical precision to exclude a poten- 3. Does prenatal vitamin K supplementation reduce tial benefit. The final study10 was inconclusive since the risk of hemorrhagic disease in the newborns of all WWE who had offspring with MCMs had folic WWE taking AEDs? acid supplementation. 4. Do maternally ingested AEDs cross the placenta Conclusion. The risk of MCMs in the offspring of or penetrate into breast milk? WWE is possibly decreased by folic acid supplemen- 5. Does indirect exposure to maternally ingested tation (two adequately sensitive Class III studies). AEDs increase the risk of symptomatic effects in Recommendation. Preconceptional folic acid sup- the newborn? plementation in WWE may be considered to reduce 6. Are there changes in AED levels during preg- the risk of MCMs (Level C). nancy in WWE? Clinical context. Folic acid supplementation is gen- erally recommended to reduce the risk of MCMs DESCRIPTION OF THE ANALYTIC PROCESS during pregnancy,11 and although the data are insuf- The panel formation, literature search strategy, and ficient to show that it is effective in WWE, there is literature analytic process are described in the com- panion article on WWE and obstetrical complica- no evidence of harm and no reason to suspect that it tions and seizure change.4 would not be effective in this group. Therefore, the strength of this evidence should not impact the cur- ANALYSIS OF EVIDENCE Does preconceptional rent folic acid supplementation recommendation folic acid supplementation reduce the risk of birth de- that all women of childbearing potential, with or fects in neonates of WWE taking AEDs? To be in- without epilepsy, be supplemented with at least 0.4 cluded in the analysis, articles had to measure the mg of folic acid daily prior to conception and during association between preconceptional folic acid use pregnancy.12 There was insufficient published infor- and the outcome of major congenital malformations mation to address the dosing of folic acid and (MCMs). MCMs were defined as structural abnor- whether higher doses offer greater protective benefit malities with surgical, medical, or cosmetic impor- to WWE taking AEDs. tance.5 The development of an MCM was considered an objective outcome. What is the risk of hemorrhagic disease in neonates born to WWE taking AEDs? To be included in the Eleven articles relevant to this question were iden- analysis, studies had to compare the risk of neonatal tified by the literature search. The articles were rated according to the American Academy of Neurology hemorrhagic complications in newborns of WWE (AAN) classification of therapeutic evidence scheme taking AEDs to newborns of women without epi- (see appendix e-4A on the Neurology® Web site at lepsy. Hemorrhagic complications were defined as www.neurology.org). Six studies were graded Class any hemorrhage within 24 hours of birth. Studies IV and are not discussed further. The remaining looking solely at surrogate markers of bleeding risk studies were rated Class III (see table e-1). such as coagulation factor levels were excluded. The Among the five Class III articles, one study (n ϭ risk of bias in each study was measured using the 156) showed an increased risk of MCMs with lack of AAN prognostic classification of evidence scheme folic acid supplementation (odds ratio [OR] 16.88, (appendix e-4B). 95% confidence interval [CI] 4.79–59.52).6 The fo- Ten articles were identified by the literature lic acid supplementation dose in this study was re- search. All but two articles were rated Class IV. The ported as 2.5–5 mg per day. A second Class III study remaining two articles, one Class II and one Class measured a significant association between serum fo- III, are summarized in table e-2.
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