Abstract
PurposeDrug‐induced aseptic meningitis (DIAM) is an inflammation of the membranes of the central nervous system caused by certain medications. It is a rare clinical entity whose risk factors are not yet fully elucidated. A local pattern of disproportionality within a global database of suspected adverse drug reactions (ADRs) revealed an increased reporting of aseptic meningitis and amoxicillin‐clavulanic acid (AC) in males. The aim of this report is to explore the clinical probability of a higher risk in males to support the use of statistical methods to identify subgroups at risk for adverse drug reactions.MethodsDisproportionality analysis was performed for all drug‐adverse event (AE) pairs in the entire database and for the subsets of males and females. AC‐aseptic meningitis was highlighted for an increased disproportionality in the male subgroup in the absence of an elevated disproportionality measure for the database overall. A clinical review was undertaken.ResultsClinical review revealed a similar statistical pattern of gender difference observed for amoxicillin, evidence to suggest a delayed type 4 hypersensitivity reaction with Th1 cells as a mechanism for amoxicillin‐aseptic meningitis, the existence of sex differences in immune responses (Th1/Th2), and an analogous increased risk of drug‐induced liver injury by AC in males.ConclusionsSubgroup disproportionality analysis has revealed a larger than expected number of reports of aseptic meningitis after amoxicillin and AC in males. Evidence synthesis supports the statistical finding. Further exploration of spontaneous databases with more extensive analyses could usher in a new era of “precision pharmacovigilance.”
Highlights
Drug‐induced aseptic meningitis (DIAM) is an inflammation of the membranes of the central nervous system caused by the administration of certain medications
A higher than expected number of reports of aseptic meningitis after amoxicillin and amoxicillin‐clavulanate have been received from males into a global database of suspected adverse drug reactions
Sex differences in immune responses, such as delayed type hypersensitivity reactions, which can be a mechanism for drug induced aseptic meningitis, have been described
Summary
Drug‐induced aseptic meningitis (DIAM) is an inflammation of the membranes of the central nervous system caused by the administration of certain medications. The diagnosis of DIAM is often one of exclusion of more common infectious causes of meningitis. Cases of DIAM caused by amoxicillin and amoxicillin‐clavulanic acid (AC) have been extensively reported in the literature, and a series of reviews have summarised a number of aspects of DIAM from the published case reports. The most commonly reported agents to cause DIAM are non‐steroidal anti‐inflammatory agents, antimicrobials, intravenous immunoglobulins, OKT3 antibodies, and anticonvulsants. Systemic lupus erythematous is the most common underlying condition reported with DIAM. Recurrent episodes of DIAM have been described in multiple case reports; such patients are predominantly females and a large proportion have underlying inflammatory diseases.[1,2]
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