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May 22, 2012; 78 (21) Articles

Comparative safety of antiepileptic drugs during pregnancy

S. Hernández-Díaz, C.R. Smith, A. Shen, R. Mittendorf, W.A. Hauser, M. Yerby, L.B. Holmes, For the North American AED Pregnancy Registry
First published May 2, 2012, DOI: https://doi.org/10.1212/WNL.0b013e3182574f39
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Article Information

vol. 78 no. 21 1692-1699
DOI: 
https://doi.org/10.1212/WNL.0b013e3182574f39
PubMed: 
22551726
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received August 30, 2011
  • Accepted January 25, 2012
  • First Published May 2, 2012.

Article Versions

Copyright & Usage: 
Copyright © 2012 by AAN Enterprises, Inc.

Author Disclosures

    1. S. Hernández-Díaz, MD, DrPH,
    2. C.R. Smith, MPH,
    3. A. Shen, MPH,
    4. R. Mittendorf, MD, DrPH,
    5. W.A. Hauser, MD,
    6. M. Yerby, MD,
    7. L.B. Holmes, MD and
    8. For the North American AED Pregnancy Registry
  1. S. Hernández-Díaz, MD, DrPH,
    2. Scientific Advisory Boards:

    1. Served as scientific advisory board for Novartis and GSK Pregnancy Registries.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consultant for Data safety monitory board for Novartis.

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Salary support (2.5-5%) from funds provided by sponsors of the North American AED Pregnancy Registry: Abbott, Eisai, Novartis, Ortho-McNeil, Pfizer and Sunovion Pharmaceuticals.

    Research Support, Government Entities:

    1. NIH R01 HD046595-01A1. (MPI: Hernández-Díaz) Teratogenicity of Drugs Commonly Used in Pregnancy. National Institute of Child and Human Development. 2005- 2013 NIH R01 HD056940-01A2. (MPI: Hernández-Díaz) Assessment of Infant Outcomes after in utero Exposure to Antiretroviral Therapy. 2009-2012. NIH R01 HD059861-01A1 National Institute of Environmental Health Sciences. (MPI: Hernández-Díaz) Phthalates in Medications and the Risk of Male Genital Malformations. 2009-2013. AHRQ (MPI: Hernández-Díaz) Anti-Depressants during Pregnancy Postpartum: Safety and Effectiveness. 2009-2014. NIH U01 HD52104-01. NICHD.(PI: Van Dyke) Pediatric HIV/AIDS Cohort Study (PHACS) – Coordination Center. 2005- 2011.

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. C.R. Smith, MPH,
    3. Scientific Advisory Boards:

    1. 1) National Pregnancy Registry for Atypical Antipsychotics

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1) Abbott 2) Eisai 3) Novartis 4) Ortho-McNeil 5) Pfizer 6) Sunovion 7) Aurobindo 8) Dr Reddy’s Lab 9) GSK 10) Sanoz 11) Teva

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. A. Shen, MPH,
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Received financial assistance from Tufts University (while a MPH student) to attend and present at the 2010 American Public Health Association annual meeting.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. 1) Abbott 2) Eisai 3) Novartis 4) Ortho-McNeil 5) Pfizer 6) Sunovion 7) Aurobindo 8) Dr Reddy’s Labs 9) GSK 10) Sandoz 11) Teva

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. R. Mittendorf, MD, DrPH,
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Current Health Reviews for Women, 2002-2011

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. Australian Research Centre for Health of Women and Babies, Adelaide, SA. AMICABLE (Antenatal Magnesium IPD International Collaboration: Assessing the Benefits for Babies using the Best Level of Evidence). Co-Principal Investigator.

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. W.A. Hauser, MD,
    6. Scientific Advisory Boards:

    1. DSMB NINDS neurocysticercosis treatment King Pharma Pharma diazepam injector DSMB Cephalon

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Editorial board Acta Neurologica Scandinavia 2000 present Editorial board Neuroepidemiology 2005 present Editorial board Epilepsy Research 2000 present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. 1. Pfizer, Consultant, 2010 2. Neuropace Consultant 2011

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. Developmental disabilities in Children with epilepsy PI David Lindenbaum, University of Kansas, Lawrence. Consultant CDC 2008-2011 INCIDENCE AND PROGNOSIS OF EPILEPSY IN HARLEM, NY: CDC PI: Dale Hesdorffer Grant #: 1 U48 DP001916-01 coinvestigator S109/30/09 - 09/29/14 FAA consultant neurologist

    Research Support, Academic Entities:

    1. Mayo Clinic, Senior Visiting Scientist, 1984 present

    Research Support, Foundations and Societies:

    1. Hotchkiss Neurological Institute, external reviewer 2008- 2010

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. FAA Consultant

  6. M. Yerby, MD,
    7. Scientific Advisory Boards:

    1. North American AED and Pregnancy Registry - Non Profit entity Speakers’ Bureaus: Lundbeck Speaker’s bureau UCB Speaker’s bureau

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Clinical trial support from Vanquix, and UCB

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. L.B. Holmes, MD and
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers’ Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Abbott, Eisai, Novartis, Ortho McNeil, Pfizer and Sunovion

    Research Support, Government Entities:

    1. Supported, in part, by a subcontract from the Center for Birth Defects Research and Prevention in the Massachusetts Department of Public Health, Boston, MA

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. For the North American AED Pregnancy Registry
    1. North American AED (Antiepileptic Drug) Pregnancy RegistryScientific Advisory Committee
  9. North American AED (Antiepileptic Drug) Pregnancy RegistryScientific Advisory Committee
    1. North American AED Pregnancy Registry
  10. North American AED Pregnancy Registry
  1. From the Department of Epidemiology (S.H.-D., C.R.S.), Harvard School of Public Health, Boston, MA; North American AED Pregnancy Registry (A.S., L.B.H.), MassGeneral Hospital for Children, Boston, MA; Loyola University Health System (R.M.), Chicago, IL; College of Physicians and Surgeons and Mailman School of Public Health (W.A.H.), Columbia University, New York, NY; and Oregon Health and Science University (M.Y.), Portland, OR.
  1. Correspondence & reprint requests to Dr. Hernández-Díaz: shernan{at}hsph.harvard.edu
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Cited By...

Disputes & Debates: Rapid online correspondence

  • Response to Maheshwari et al.
    • Sonia Hernandez-Diaz, Associate Professor, Harvard School of Public Health
    • Lewis B. Holmes, Boston, MA, USA
    Submitted September 07, 2012
  • Are newer antiepileptics really safer?
    • Amit Maheshwari, senior resident neurology, SAIMS Indore India
    • Amit Maheshwari,Sunil Athale,O.P.Lekhra,Kapil Telang-all Indore India
    Submitted August 28, 2012
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