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March 20, 2012; 78 (12) Contemporary Issues in Neurologic Practice

Lamotrigine and aseptic meningitis

Kelley M. Simms, Cindy Kortepeter, Mark Avigan
First published February 22, 2012, DOI: https://doi.org/10.1212/WNL.0b013e31824c4634
Kelley M. Simms
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Cindy Kortepeter
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Lamotrigine and aseptic meningitis
Kelley M. Simms, Cindy Kortepeter, Mark Avigan
Neurology Mar 2012, 78 (12) 921-927; DOI: 10.1212/WNL.0b013e31824c4634

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Abstract

Objective: The purpose of this case series is to characterize a recently identified association of the antiepileptic drug (AED) lamotrigine with aseptic meningitis based on cases reported to the Food and Drug Administration (FDA)'s Adverse Event Reporting System (AERS) database.

Methods: We performed a data mining analysis of 9 AEDs from the FDA's AERS database. We applied the multi-item gamma Poisson shrinker (MGPS) algorithm to the entire AERS database through November 2, 2009, to generate empirical Bayes geometric mean (EBGM) values with corresponding confidence intervals for 9 AEDs and the adverse event code “meningitis aseptic.” The AERS database was also searched for postmarketing reports of aseptic meningitis associated with lamotrigine and a detailed review of each case was performed.

Results: Forty AERS cases were identified in this review. Findings from the AERS reports revealed CSF profiles with features of both bacterial as well as viral meningitis. Fifteen cases documented a positive rechallenge; the median time to onset of symptoms upon rechallenge was only 60 minutes. Data mining analysis of several anticonvulsants resulted in disproportionate reporting solely for lamotrigine.

Conclusion: There appears to be an association between lamotrigine use and aseptic meningitis. It is notable that nearly 40% of cases in this case series reported a positive rechallenge. Lamotrigine-associated aseptic meningitis should be considered in the differential diagnosis of culture-negative meningitis. This case series highlights the need for continued pharmacovigilance and the importance of systematic monitoring of patients treated with antiepileptic medications.

GLOSSARY

AED=
antiepileptic drug;
AERS=
Adverse Event Reporting System;
DRESS=
drug reaction with eosinophilia and systemic symptoms;
EBGM=
empirical Bayes geometric mean;
FDA=
Food and Drug Administration;
MedDRA=
Medical Dictionary for Regulatory Activities;
MGPS=
multi-item gamma Poisson shrinker;
PMN=
polymorphonuclear leukocyte;
PT=
preferred term;
WBC=
white blood cell

Footnotes

  • ↵* These authors contributed equally to this work.

  • Editorial, page 849

  • Disclaimer: The views expressed are those of the authors and do not necessarily represent those of, nor imply endorsement from, the US Food and Drug Administration or the US government.

  • Received February 22, 2011.
  • Accepted August 2, 2011.
  • Copyright © 2012 by AAN Enterprises, Inc.
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Disputes & Debates: Rapid online correspondence

  • Re:Lamotrigine and aseptic meningitis
    • William O. Tatum, Professor, Mayo Clinic, Jacksonville, Floridatatum.william@mayo.edu
    • Jacqueline French, New York, New York
    Submitted March 29, 2012
  • Lamotrigine and aseptic meningitis
    • Kelley M. Simms, PharmD, Food and Drug Adminstrationkelley.simms@fda.hhs.gov
    • Kelley M Simms, Silver Spring, MD; Cindy Kortepeter, Silver Spring, MD; Mark Avigan, Silver Spring, MD
    Submitted March 23, 2012
  • Aseptic meningitis due to lamotrigine use: when the benefits outweigh the risks
    • Nitin K. Sethi, Assistant Professor of Neurology, New York-Presbyterian Hospital, Weill Cornell Medical Center, 525 East 68th Street, New York, NY 100sethinitinmd@hotmail.com
    Submitted March 23, 2012
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