Lamotrigine and aseptic meningitis

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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

GLOSSARY

AERS: Adverse Event Reporting System

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DRESS: drug reaction with eosinophilia and systemic symptoms

GLOSSARY

EBGM: empirical Bayes geometric mean

GLOSSARY

FDA: Food and Drug Administration

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MedDRA: Medical Dictionary for Regulatory Activities

GLOSSARY

MGPS: multi-item gamma Poisson shrinker

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PMN: polymorphonuclear leukocyte

GLOSSARY

PT: preferred term

GLOSSARY

WBC: white blood cell

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