Oseltamivir and the Risk of Neuropsychiatric Events: A National, Population-based Study

Abstract

BACKGROUND: Reports of serious neuropsychiatric events (NPEs), specifically suicide/suicide attempts, following the use of oseltamivir have led to public concerns. Our aim in this study was to determine whether an association exists between oseltamivir use and NPEs. METHOD: This study was a population-based, retrospective, cohort study on a random sample of 50% of individuals in the Korean National Health Insurance Service (KNIS) database aged ≥8 years who were diagnosed with influenza between 2009 and 2017. The primary exposure was oseltamivir prescription at the time of influenza diagnosis, whereas the primary outcome was a diagnosis of an NPE within 30 days after the influenza diagnosis. Information on oseltamivir prescription, diagnoses of NPEs, demographic characteristics, comorbidities, drugs prescribed within the year before influenza diagnosis, and healthcare utilization were extracted from the KNIS database. RESULTS: Of 3 352 015 individuals included in the analysis, 1 266 780 (37.8%) were prescribed oseltamivir. The incidence of NPEs was 0.86% and 1.16% in patients who were and were not prescribed oseltamivir, respectively (hazard ratio [HR], 0.74; 95% confidence interval [CI], .73 to .75; P < .001). Oseltamivir use was not associated with a difference in the overall risk of NPEs in the adjusted model (HR, 0.98; 95% CI, .96 to 1.01; P = .16), but the incidence of moderate-to-severe NPEs was significantly lower in those prescribed oseltamivir (HR, 0.92; 95% CI, .88-.96; P < .001). CONCLUSION: Treating influenza with oseltamivir does not increase the risk of NPEs. Thus, public concern regarding its use is unwarranted.