Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: 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; K. J. Meador; P. B. Pennell; W. A. Hauser; G. S. Gronseth; J. A. French; S. Wiebe; D. Thurman; B. S. Koppel; P. W. Kaplan; J. N. Robinson; J. Hopp; T. Y. Ting; B. Gidal; C. A. Hovinga; A. N. Wilner; B. Vazquez; L. Holmes; A. Krumholz; R. Finnell; D. Hirtz; C. Le Guen

doi:10.1212/WNL.0b013e3181a6b312

Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: 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, K. J. Meador, P. B. Pennell, W. A. Hauser, G. S. Gronseth, J. A. French, S. Wiebe, D. Thurman, B. S. Koppel, P. W. Kaplan, J. N. Robinson, J. Hopp, T. Y. Ting, B. Gidal, C. A. Hovinga, A. N. Wilner, B. Vazquez, L. Holmes, A. Krumholz, R. FinnellD. Hirtz, C. Le Guen

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVE: To reassess the evidence for management issues related to the care of women with epilepsy (WWE) during pregnancy. METHODS: Systematic review of relevant articles published between January 1985 and June 2007. RESULTS: It is highly probable that intrauterine first-trimester valproate (VPA) exposure has higher risk of major congenital malformations (MCMs) compared to carbamazepine and possible compared to phenytoin or lamotrigine. Compared to untreated WWE, it is probable that VPA as part of polytherapy and possible that VPA as monotherapy contribute to the development of MCMs. It is probable that antiepileptic drug (AED) polytherapy as compared to monotherapy regimens contributes to the development of MCMs and to reduced cognitive outcomes. For monotherapy, intrauterine exposure to VPA probably reduces cognitive outcomes. Further, monotherapy exposure to phenytoin or phenobarbital possibly reduces cognitive outcomes. Neonates of WWE taking AEDs probably have an increased risk of being small for gestational age and possibly have an increased risk of a 1-minute Apgar score of <7. RECOMMENDATIONS: If possible, avoidance of valproate (VPA) and antiepileptic drug (AED) polytherapy during the first trimester of pregnancy should be considered to decrease the risk of major congenital malformations (Level B). If possible, avoidance of VPA and AED polytherapy throughout pregnancy should be considered to prevent reduced cognitive outcomes (Level B). If possible, avoidance of phenytoin and phenobarbital during pregnancy may be considered to prevent reduced cognitive outcomes (Level C). Pregnancy risk stratification should reflect that the offspring of women with epilepsy taking AEDs are probably at increased risk for being small for gestational age (Level B) and possibly at increased risk of 1-minute Apgar scores of <7 (Level C).

Original language	English (US)
Pages (from-to)	133-141
Number of pages	9
Journal	Neurology
Volume	73
Issue number	2
DOIs	https://doi.org/10.1212/WNL.0b013e3181a6b312
State	Published - Jul 2009

ASJC Scopus subject areas

Clinical Neurology

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Harden, C. L., Meador, K. J., Pennell, P. B., Hauser, W. A., Gronseth, G. S., French, J. A., Wiebe, S., Thurman, D., Koppel, B. S., Kaplan, P. W., Robinson, J. N., Hopp, J., Ting, T. Y., Gidal, B., Hovinga, C. A., Wilner, A. N., Vazquez, B., Holmes, L., Krumholz, A., ... Le Guen, C. (2009). Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology, 73(2), 133-141. https://doi.org/10.1212/WNL.0b013e3181a6b312

Practice parameter update : Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. / Harden, C. L.; Meador, K. J.; Pennell, P. B.; Hauser, W. A.; Gronseth, G. S.; French, J. A.; Wiebe, S.; Thurman, D.; Koppel, B. S.; Kaplan, P. W.; Robinson, J. N.; Hopp, J.; Ting, T. Y.; Gidal, B.; Hovinga, C. A.; Wilner, A. N.; Vazquez, B.; Holmes, L.; Krumholz, A.; Finnell, R.; Hirtz, D.; Le Guen, C.

In: Neurology, Vol. 73, No. 2, 07.2009, p. 133-141.

Research output: Contribution to journal › Article › peer-review

Harden, CL, Meador, KJ, Pennell, PB, Hauser, WA, Gronseth, GS, French, JA, Wiebe, S, Thurman, D, Koppel, BS, Kaplan, PW, Robinson, JN, Hopp, J, Ting, TY, Gidal, B, Hovinga, CA, Wilner, AN, Vazquez, B, Holmes, L, Krumholz, A, Finnell, R, Hirtz, D & Le Guen, C 2009, 'Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society', Neurology, vol. 73, no. 2, pp. 133-141. https://doi.org/10.1212/WNL.0b013e3181a6b312

Harden CL, Meador KJ, Pennell PB, Hauser WA, Gronseth GS, French JA et al. Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology. 2009 Jul;73(2):133-141. https://doi.org/10.1212/WNL.0b013e3181a6b312

Harden, C. L. ; Meador, K. J. ; Pennell, P. B. ; Hauser, W. A. ; Gronseth, G. S. ; French, J. A. ; Wiebe, S. ; Thurman, D. ; Koppel, B. S. ; Kaplan, P. W. ; Robinson, J. N. ; Hopp, J. ; Ting, T. Y. ; Gidal, B. ; Hovinga, C. A. ; Wilner, A. N. ; Vazquez, B. ; Holmes, L. ; Krumholz, A. ; Finnell, R. ; Hirtz, D. ; Le Guen, C. / Practice parameter update : Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. In: Neurology. 2009 ; Vol. 73, No. 2. pp. 133-141.

@article{014047b722f343b7831f432faba90297,

title = "Practice parameter update: Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society",

abstract = "OBJECTIVE: To reassess the evidence for management issues related to the care of women with epilepsy (WWE) during pregnancy. METHODS: Systematic review of relevant articles published between January 1985 and June 2007. RESULTS: It is highly probable that intrauterine first-trimester valproate (VPA) exposure has higher risk of major congenital malformations (MCMs) compared to carbamazepine and possible compared to phenytoin or lamotrigine. Compared to untreated WWE, it is probable that VPA as part of polytherapy and possible that VPA as monotherapy contribute to the development of MCMs. It is probable that antiepileptic drug (AED) polytherapy as compared to monotherapy regimens contributes to the development of MCMs and to reduced cognitive outcomes. For monotherapy, intrauterine exposure to VPA probably reduces cognitive outcomes. Further, monotherapy exposure to phenytoin or phenobarbital possibly reduces cognitive outcomes. Neonates of WWE taking AEDs probably have an increased risk of being small for gestational age and possibly have an increased risk of a 1-minute Apgar score of <7. RECOMMENDATIONS: If possible, avoidance of valproate (VPA) and antiepileptic drug (AED) polytherapy during the first trimester of pregnancy should be considered to decrease the risk of major congenital malformations (Level B). If possible, avoidance of VPA and AED polytherapy throughout pregnancy should be considered to prevent reduced cognitive outcomes (Level B). If possible, avoidance of phenytoin and phenobarbital during pregnancy may be considered to prevent reduced cognitive outcomes (Level C). Pregnancy risk stratification should reflect that the offspring of women with epilepsy taking AEDs are probably at increased risk for being small for gestational age (Level B) and possibly at increased risk of 1-minute Apgar scores of <7 (Level C).",

author = "Harden, {C. L.} and Meador, {K. J.} and Pennell, {P. B.} and Hauser, {W. A.} and Gronseth, {G. S.} and French, {J. A.} and S. Wiebe and D. Thurman and Koppel, {B. S.} and Kaplan, {P. W.} and Robinson, {J. N.} and J. Hopp and Ting, {T. Y.} and B. Gidal and Hovinga, {C. A.} and Wilner, {A. N.} and B. Vazquez and L. Holmes and A. Krumholz and R. Finnell and D. Hirtz and {Le Guen}, C.",

note = "Funding Information: The authors report the following conflicts of interest: Dr. Harden has served on the scientific advisory board of Cyberonics, GlaxoSmithKline, UCB Pharma, Valeant, and SK Pharmaceuticals and on the speakers' bureau of GlaxoSmithKline, Pfizer, UCB Pharma, and Abbott. She serves as an editor of Epilepsy Currents and receives publishing royalties from Elsevier. Dr. Harden has received research funding from Forest, UCB Pharma, Ortho McNeil, and NIH/NINDS. Dr. Harden sees women with epilepsy in her office practice. Dr. Meador serves as a journal editor for Neurology, Journal of Clinical Neurophysiology, Cognitive and Behavioral Neurology, Epilepsy & Behavior, Epilepsy Currents , and Epilepsy.com . He has received research funding from NIH/NINDS, GlaxoSmithKline, Eisai, Marius, Myriad, Neuropace, SAM Technology, and UCB Pharma. Dr. Meador estimates that 30–40% of his clinical effort is spent on EEGs and the clinical care of patients with epilepsy. Dr. Pennell has served on the Expert Panel for the Keppra Pregnancy Registry sponsored by UCB Pharma. She has received funding for travel from the Northeast Regional Epilepsy Group for speaking at their 2008 Epilepsy Symposium, by the UK Research Council for speaking at the Epilepsy Research UK International Expert Workshop, by UCB Pharma for attending the Executive Panel meeting for the Pregnancy Registry, by the American Epilepsy Society for attending the Board of Directors' Meeting, by the Epilepsy Foundation for attending the Board of Directors' and orientation meetings, by the Long Island Jewish Hospital for lecturing at Neurology Grand Rounds, by Duke University for lecturing at Neurology Grand Rounds, by Brigham and Women's Hospital for lecturing at the Epilepsy Research Conference, by the Milken foundation for attending Pregnancy Registry meetings, and by Massachusetts General Hospital for speaking at the Annual Teratogens Course. She has received honoraria from Journal Watch Neurology for a contributing article, paid for by Massachusetts Medical Society, NEJM , for review for the Lancet Neurology , the Northeast Regional Epilepsy group for speaking at 2008 Epilepsy Symposium, North Shore Long Island Jewish Health system, Duke University, University of Maryland, the Massachusetts General Hospital for speaking at the postgraduate course in Human Teratogens, and the AAN for speaking and directing annual courses. Dr. Pennell has served as a contributing editor for Epilepsy Currents and is on the editorial board of Epilepsia . Dr. Pennell has received research support from UCB Pharma, Marinus Pharmaceuticals, NIH, NINDS, NIMH, CDC, and Emory University Research Council. Dr. Hauser has served on the scientific advisory board of Ovation and Valeant. He has served on the editorial board of Acta Neurologica Scandinavia, Neuroepidemiology , and Epilepsy Research . He has received honoraria from Cornell University Symposium on epilepsy and acted as a consultant to Pfizer. Dr. Hauser has received research support from AAMC/CDC, NIH/NINDS, FAA, Mayo Clinic, and Hotchkiss Neurological Institute, and has given expert testimony in his role as an FAA consultant. Dr. Gronseth serves as an editor of Neurology Now and on the speakers' bureau of Boehringer-Ingelheim. He receives compensation from the AAN for consulting work. Dr. French has served on the scientific advisory board of UCB Pharma, Johnson and Johnson, Eisai, Novartis, Valeant, Icagen, Intranasal, Sepracor, and Marinus. She has received funding for travel to present findings or give lectures from UCB Pharma, Kyowa, Eisai, Johnson and Johnson, Valeant, and GlaxoSmithKline. She has served as an associate editor for Epilepsy Currents and supplement editor for Epileptic Disorders . Dr. French is the president of the Epilepsy Study Consortium, which receives money from multiple pharmaceutical companies (including GlaxoSmithKline, UCB Pharma, Johnson and Johnson, Cyberonics, Schwarz Pharma, Ortho McNeil, Eisai, Jazz Pharmaceuticals, Ovation Pharmaceuticals, Endo Pharmaceuticals, Bial Pharmaceuticals, Neurovista, Valeant Pharmaceuticals, Icagen, Supernus, Intranasal, SK Pharmaceuticals, Taro Pharmaceuticals, Neurotherapeutics, Sepracor, and Novartis) and she consults on behalf of the consortium. Dr. French has received research funding from Johnson and Johnson, Eisai, UCB Pharma, SK Pharmaceuticals, Valeant, Pfizer, NIH, and Epilepsy Research Foundation. Dr. Wiebe serves on the editorial board of Neurology, Epilepsia, Epilepsy & Behavior , and Canadian Journal of Neurological Sciences. Dr. Thurman is an employee of the CDC. Dr. Koppel reports no disclosures. Dr. Kaplan has served on the speakers' bureau of UCB Pharma, GSK, and Ortho McNeil. He serves as an associate editor for Neurophysiologie Clinique, Journal of Clinical Neurophysiology , and Epilepsia . He receives royalties from Demos Publications for the books Neurological Disease in Women, Epilepsy A to Z, Imitators of Epilepsy , and Nonconvulsive Status Epilepticus . He has received speaker honoraria from Medical College of South Carolina, Duke University, and Medical College of Virginia, has received research funding from NIH, Schwarz, Ortho McNeil, and Pfizer, and has acted as a consultant for Schering-Plough and Infinite Biological Technologies. Dr. Robinson reports no disclosures. Dr. Hopp receives royalties from UpToDate.com electronic medical journal. She has been on the speakers' bureau of UCB Pharma and GlaxoSmithKline. Dr. Hopp has given testimony in a medico-legal case. Dr. Ting served on the scientific advisory board of UCB Pharma and has received honoraria from the Epilepsy Foundation of America. Dr. Gidal has served on the scientific advisory board for GlaxoSmithKline, UCB Pharma, and Abbott Labs and served as an editor for Epilepsy & Behavior, The Annals of Pharmacotherapy , and Pharmacist's Letter. Dr. Gidal has received research support from UCB Pharma. Dr. Hovinga estimates less than 10% of his clinical effort is spent on pharmacology consults. Dr. Wilner has served on the scientific advisory board of and received funding for travel from GlaxoSmithKline. He receives royalties from Demos Publications for Epilepsy: 199 Answers and Epilepsy in Clinical Practice . He receives board of directors compensation from GlaxoSmithKline. Dr. Vazquez has served on the scientific advisory board of Eisai, UCB, GSK, and Ortho McNeil. She has received honoraria from UCB, GSK, Ortho McNeil, and Eisai. Dr. Vazquez has served on a speakers' bureau for Eisai, GSK, Ortho McNeil, UCB, and Novartis. Dr. Holmes receives research support from Abbott Labs, Eisai, Novartis, Ortho McNeil, and Pfizer. Dr. Krumholz has served on the Department of Transportation Expert Panel on Commercial Drivers and Epilepsy and has served on the editorial board of The Neurologist and Clinical EEG and Neuroscience. He has received honoraria from the Robert Wood Johnson Medical School for grand rounds. Dr. Finnell has served on the scientific advisory board of the NEAD study at Emory University, the University of Houston Center for Life Sciences Technology, the NIH, and the NIEHS National Advisory Environmental Health Sciences Council. He has received funding for travel from Fundacion BBVA, NIEHS National Advisory Environmental Health Sciences Council, IKMC Steering Committee, European Epilepsy Meeting, NIH, and AES. Dr. Finnell has served as a journal editor for Birth Defects Research Part A and holds a patent on folate receptor autoantibody assay. He has received honoraria from McGill University-Montreal Neurological Institute and has received research funding from the Centers for Disease Control and Prevention for the National Birth Defects Prevention Study and the Methodist Hospital Research Institute. Dr. Finnell has given expert testimony, prepared affadavits, and acted as a witness regarding legal proceedings related to the topic of this manuscript. Dr. Hirtz reports no disclosures. Ms. Le Guen reports no disclosures. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",

year = "2009",

month = jul,

doi = "10.1212/WNL.0b013e3181a6b312",

language = "English (US)",

volume = "73",

pages = "133--141",

journal = "Neurology",

issn = "0028-3878",

publisher = "Lippincott Williams and Wilkins",

number = "2",

}

TY - JOUR

T1 - Practice parameter update

T2 - Management issues for women with epilepsy - Focus on pregnancy (an evidence-based review): Teratogenesis and perinatal outcomes: Report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society

AU - Harden, C. L.

AU - Meador, K. J.

AU - Pennell, P. B.

AU - Hauser, W. A.

AU - Gronseth, G. S.

AU - French, J. A.

AU - Wiebe, S.

AU - Thurman, D.

AU - Koppel, B. S.

AU - Kaplan, P. W.

AU - Robinson, J. N.

AU - Hopp, J.

AU - Ting, T. Y.

AU - Gidal, B.

AU - Hovinga, C. A.

AU - Wilner, A. N.

AU - Vazquez, B.

AU - Holmes, L.

AU - Krumholz, A.

AU - Finnell, R.

AU - Hirtz, D.

AU - Le Guen, C.

N1 - Funding Information: The authors report the following conflicts of interest: Dr. Harden has served on the scientific advisory board of Cyberonics, GlaxoSmithKline, UCB Pharma, Valeant, and SK Pharmaceuticals and on the speakers' bureau of GlaxoSmithKline, Pfizer, UCB Pharma, and Abbott. She serves as an editor of Epilepsy Currents and receives publishing royalties from Elsevier. Dr. Harden has received research funding from Forest, UCB Pharma, Ortho McNeil, and NIH/NINDS. Dr. Harden sees women with epilepsy in her office practice. Dr. Meador serves as a journal editor for Neurology, Journal of Clinical Neurophysiology, Cognitive and Behavioral Neurology, Epilepsy & Behavior, Epilepsy Currents , and Epilepsy.com . He has received research funding from NIH/NINDS, GlaxoSmithKline, Eisai, Marius, Myriad, Neuropace, SAM Technology, and UCB Pharma. Dr. Meador estimates that 30–40% of his clinical effort is spent on EEGs and the clinical care of patients with epilepsy. Dr. Pennell has served on the Expert Panel for the Keppra Pregnancy Registry sponsored by UCB Pharma. She has received funding for travel from the Northeast Regional Epilepsy Group for speaking at their 2008 Epilepsy Symposium, by the UK Research Council for speaking at the Epilepsy Research UK International Expert Workshop, by UCB Pharma for attending the Executive Panel meeting for the Pregnancy Registry, by the American Epilepsy Society for attending the Board of Directors' Meeting, by the Epilepsy Foundation for attending the Board of Directors' and orientation meetings, by the Long Island Jewish Hospital for lecturing at Neurology Grand Rounds, by Duke University for lecturing at Neurology Grand Rounds, by Brigham and Women's Hospital for lecturing at the Epilepsy Research Conference, by the Milken foundation for attending Pregnancy Registry meetings, and by Massachusetts General Hospital for speaking at the Annual Teratogens Course. She has received honoraria from Journal Watch Neurology for a contributing article, paid for by Massachusetts Medical Society, NEJM , for review for the Lancet Neurology , the Northeast Regional Epilepsy group for speaking at 2008 Epilepsy Symposium, North Shore Long Island Jewish Health system, Duke University, University of Maryland, the Massachusetts General Hospital for speaking at the postgraduate course in Human Teratogens, and the AAN for speaking and directing annual courses. Dr. Pennell has served as a contributing editor for Epilepsy Currents and is on the editorial board of Epilepsia . Dr. Pennell has received research support from UCB Pharma, Marinus Pharmaceuticals, NIH, NINDS, NIMH, CDC, and Emory University Research Council. Dr. Hauser has served on the scientific advisory board of Ovation and Valeant. He has served on the editorial board of Acta Neurologica Scandinavia, Neuroepidemiology , and Epilepsy Research . He has received honoraria from Cornell University Symposium on epilepsy and acted as a consultant to Pfizer. Dr. Hauser has received research support from AAMC/CDC, NIH/NINDS, FAA, Mayo Clinic, and Hotchkiss Neurological Institute, and has given expert testimony in his role as an FAA consultant. Dr. Gronseth serves as an editor of Neurology Now and on the speakers' bureau of Boehringer-Ingelheim. He receives compensation from the AAN for consulting work. Dr. French has served on the scientific advisory board of UCB Pharma, Johnson and Johnson, Eisai, Novartis, Valeant, Icagen, Intranasal, Sepracor, and Marinus. She has received funding for travel to present findings or give lectures from UCB Pharma, Kyowa, Eisai, Johnson and Johnson, Valeant, and GlaxoSmithKline. She has served as an associate editor for Epilepsy Currents and supplement editor for Epileptic Disorders . Dr. French is the president of the Epilepsy Study Consortium, which receives money from multiple pharmaceutical companies (including GlaxoSmithKline, UCB Pharma, Johnson and Johnson, Cyberonics, Schwarz Pharma, Ortho McNeil, Eisai, Jazz Pharmaceuticals, Ovation Pharmaceuticals, Endo Pharmaceuticals, Bial Pharmaceuticals, Neurovista, Valeant Pharmaceuticals, Icagen, Supernus, Intranasal, SK Pharmaceuticals, Taro Pharmaceuticals, Neurotherapeutics, Sepracor, and Novartis) and she consults on behalf of the consortium. Dr. French has received research funding from Johnson and Johnson, Eisai, UCB Pharma, SK Pharmaceuticals, Valeant, Pfizer, NIH, and Epilepsy Research Foundation. Dr. Wiebe serves on the editorial board of Neurology, Epilepsia, Epilepsy & Behavior , and Canadian Journal of Neurological Sciences. Dr. Thurman is an employee of the CDC. Dr. Koppel reports no disclosures. Dr. Kaplan has served on the speakers' bureau of UCB Pharma, GSK, and Ortho McNeil. He serves as an associate editor for Neurophysiologie Clinique, Journal of Clinical Neurophysiology , and Epilepsia . He receives royalties from Demos Publications for the books Neurological Disease in Women, Epilepsy A to Z, Imitators of Epilepsy , and Nonconvulsive Status Epilepticus . He has received speaker honoraria from Medical College of South Carolina, Duke University, and Medical College of Virginia, has received research funding from NIH, Schwarz, Ortho McNeil, and Pfizer, and has acted as a consultant for Schering-Plough and Infinite Biological Technologies. Dr. Robinson reports no disclosures. Dr. Hopp receives royalties from UpToDate.com electronic medical journal. She has been on the speakers' bureau of UCB Pharma and GlaxoSmithKline. Dr. Hopp has given testimony in a medico-legal case. Dr. Ting served on the scientific advisory board of UCB Pharma and has received honoraria from the Epilepsy Foundation of America. Dr. Gidal has served on the scientific advisory board for GlaxoSmithKline, UCB Pharma, and Abbott Labs and served as an editor for Epilepsy & Behavior, The Annals of Pharmacotherapy , and Pharmacist's Letter. Dr. Gidal has received research support from UCB Pharma. Dr. Hovinga estimates less than 10% of his clinical effort is spent on pharmacology consults. Dr. Wilner has served on the scientific advisory board of and received funding for travel from GlaxoSmithKline. He receives royalties from Demos Publications for Epilepsy: 199 Answers and Epilepsy in Clinical Practice . He receives board of directors compensation from GlaxoSmithKline. Dr. Vazquez has served on the scientific advisory board of Eisai, UCB, GSK, and Ortho McNeil. She has received honoraria from UCB, GSK, Ortho McNeil, and Eisai. Dr. Vazquez has served on a speakers' bureau for Eisai, GSK, Ortho McNeil, UCB, and Novartis. Dr. Holmes receives research support from Abbott Labs, Eisai, Novartis, Ortho McNeil, and Pfizer. Dr. Krumholz has served on the Department of Transportation Expert Panel on Commercial Drivers and Epilepsy and has served on the editorial board of The Neurologist and Clinical EEG and Neuroscience. He has received honoraria from the Robert Wood Johnson Medical School for grand rounds. Dr. Finnell has served on the scientific advisory board of the NEAD study at Emory University, the University of Houston Center for Life Sciences Technology, the NIH, and the NIEHS National Advisory Environmental Health Sciences Council. He has received funding for travel from Fundacion BBVA, NIEHS National Advisory Environmental Health Sciences Council, IKMC Steering Committee, European Epilepsy Meeting, NIH, and AES. Dr. Finnell has served as a journal editor for Birth Defects Research Part A and holds a patent on folate receptor autoantibody assay. He has received honoraria from McGill University-Montreal Neurological Institute and has received research funding from the Centers for Disease Control and Prevention for the National Birth Defects Prevention Study and the Methodist Hospital Research Institute. Dr. Finnell has given expert testimony, prepared affadavits, and acted as a witness regarding legal proceedings related to the topic of this manuscript. Dr. Hirtz reports no disclosures. Ms. Le Guen reports no disclosures. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.

PY - 2009/7

Y1 - 2009/7

N2 - OBJECTIVE: To reassess the evidence for management issues related to the care of women with epilepsy (WWE) during pregnancy. METHODS: Systematic review of relevant articles published between January 1985 and June 2007. RESULTS: It is highly probable that intrauterine first-trimester valproate (VPA) exposure has higher risk of major congenital malformations (MCMs) compared to carbamazepine and possible compared to phenytoin or lamotrigine. Compared to untreated WWE, it is probable that VPA as part of polytherapy and possible that VPA as monotherapy contribute to the development of MCMs. It is probable that antiepileptic drug (AED) polytherapy as compared to monotherapy regimens contributes to the development of MCMs and to reduced cognitive outcomes. For monotherapy, intrauterine exposure to VPA probably reduces cognitive outcomes. Further, monotherapy exposure to phenytoin or phenobarbital possibly reduces cognitive outcomes. Neonates of WWE taking AEDs probably have an increased risk of being small for gestational age and possibly have an increased risk of a 1-minute Apgar score of <7. RECOMMENDATIONS: If possible, avoidance of valproate (VPA) and antiepileptic drug (AED) polytherapy during the first trimester of pregnancy should be considered to decrease the risk of major congenital malformations (Level B). If possible, avoidance of VPA and AED polytherapy throughout pregnancy should be considered to prevent reduced cognitive outcomes (Level B). If possible, avoidance of phenytoin and phenobarbital during pregnancy may be considered to prevent reduced cognitive outcomes (Level C). Pregnancy risk stratification should reflect that the offspring of women with epilepsy taking AEDs are probably at increased risk for being small for gestational age (Level B) and possibly at increased risk of 1-minute Apgar scores of <7 (Level C).

AB - OBJECTIVE: To reassess the evidence for management issues related to the care of women with epilepsy (WWE) during pregnancy. METHODS: Systematic review of relevant articles published between January 1985 and June 2007. RESULTS: It is highly probable that intrauterine first-trimester valproate (VPA) exposure has higher risk of major congenital malformations (MCMs) compared to carbamazepine and possible compared to phenytoin or lamotrigine. Compared to untreated WWE, it is probable that VPA as part of polytherapy and possible that VPA as monotherapy contribute to the development of MCMs. It is probable that antiepileptic drug (AED) polytherapy as compared to monotherapy regimens contributes to the development of MCMs and to reduced cognitive outcomes. For monotherapy, intrauterine exposure to VPA probably reduces cognitive outcomes. Further, monotherapy exposure to phenytoin or phenobarbital possibly reduces cognitive outcomes. Neonates of WWE taking AEDs probably have an increased risk of being small for gestational age and possibly have an increased risk of a 1-minute Apgar score of <7. RECOMMENDATIONS: If possible, avoidance of valproate (VPA) and antiepileptic drug (AED) polytherapy during the first trimester of pregnancy should be considered to decrease the risk of major congenital malformations (Level B). If possible, avoidance of VPA and AED polytherapy throughout pregnancy should be considered to prevent reduced cognitive outcomes (Level B). If possible, avoidance of phenytoin and phenobarbital during pregnancy may be considered to prevent reduced cognitive outcomes (Level C). Pregnancy risk stratification should reflect that the offspring of women with epilepsy taking AEDs are probably at increased risk for being small for gestational age (Level B) and possibly at increased risk of 1-minute Apgar scores of <7 (Level C).

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