| アブストラクト | 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. |
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| ジャーナル名 | Neurology |
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| 投稿日 | 2012/02/24 |
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| 投稿者 | Simms, Kelley M; Kortepeter, Cindy; Avigan, Mark |
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| 組織名 | Food and Drug Administration, Center for Drug Evaluation and Research, Office of;Surveillance and Epidemiology, Silver Spring, MD, USA. Kelley.Simms@fda.hhs.gov |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/22357718/ |
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