title: Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports.
abstract: There have been concerns that oseltamivir causes neuropsychiatric adverse events (NPAEs). We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. NPAE data were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (2004 to 2013). The lower limit of the reporting odds ratio (ROR) 95% confidence interval (CI) of "abnormal behavior" in Japan, Singapore, and Taiwan was ≥1. The effects of the interaction terms for oseltamivir in male patients aged 10-19 years were statistically significant. The adjusted ROR of "abnormal behavior" was 96.4 (95% CI, 77.5-119.9) in male patients aged 10-19 years treated with osletamivir. In female patients, the results of the likelihood ratio test for "abnormal behavior" were not statistically significant. The adjusted NPAE RORs were increased in male and female patients under the age of 20 years. Oseltamivir use could be associated with "abnormal behavior" in males aged 10-19 years. After considering the causality restraints of the current analysis, further epidemiological studies are recommended.
authors.affiliation: Laboratory of Drug Informatics, Gifu Pharmaceutical University.
authors.forename: Natsumi
authors.initials: N
authors.lastname: Ueda
authors.forename: Ryogo
authors.initials: R
authors.lastname: Umetsu
authors.forename: Junko
authors.initials: J
authors.lastname: Abe
authors.forename: Yamato
authors.initials: Y
authors.lastname: Kato
authors.forename: Yoko
authors.initials: Y
authors.lastname: Nakayama
authors.forename: Zenichiro
authors.initials: Z
authors.lastname: Kato
authors.forename: Yasutomi
authors.initials: Y
authors.lastname: Kinosada
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Nakamura
mesh_terms: D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001208:Asia / Q000453:epidemiology; D001519:Behavior / Q000187:drug effects; D001526:Behavioral Symptoms; D002648:Child; D005260:Female; D006801:Humans; D007251:Influenza, Human / Q000188:drug therapy; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced*; D016017:Odds Ratio; D053139:Oseltamivir / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D053139:Oseltamivir