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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
- 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
- Lamotrigine and aseptic meningitis
- Aseptic meningitis due to lamotrigine use: when the benefits outweigh the risks
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