amoxicillin-potassium-clavulanate-combination and Meningitis--Aseptic

Drug-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.. Disproportionality 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.. Clinical 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.. Subgroup 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."

Topics: Adverse Drug Reaction Reporting Systems; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Data Interpretation, Statistical; Databases, Factual; Female; Global Health; Humans; Male; Meningitis, Aseptic; Pharmacoepidemiology; Pharmacovigilance; Risk Factors; Sex Factors

A 58-year-old man presented to the hospital with fever and headache after amoxicillin intake. Physical examination, laboratory, and a cranial CT scan were unremarkable. Cerebrospinal fluid (CSF) testing revealed lymphocytic pleocytosis. After discontinuation of amoxicillin and symptomatic care, the patient quickly improved. Interestingly, he had had two prior episodes of aseptic meningitis that were probably also related to the administration of amoxicillin. Aseptic meningitis can be caused by multiple non-infectious conditions including drugs, malignancy, and autoimmune diseases. We report a case associated with amoxicillin that meets the criteria of drug-induced aseptic meningitis. Considering the wide utilization of amoxicillin, healthcare providers should be aware of it as a possible cause of drug-induced aseptic meningitis.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Humans; Male; Meningitis, Aseptic; Middle Aged; Skin Diseases, Infectious

Topics: Amoxicillin-Potassium Clavulanate Combination; Drug Hypersensitivity; Drug Therapy, Combination; Humans; Hypersensitivity, Immediate; Immune Complex Diseases; Male; Meningitis, Aseptic; Middle Aged

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Therapy, Combination; Female; Humans; Meningitis, Aseptic; Recurrence