Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports

Natsumi Ueda, Ryogo Umetsu, Junko Abe, Yamato Kato, Yoko Nakayama, Zenichiro Kato, Yasutomi Kinosada, Mitsuhiro Nakamur

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1638-1644
Number of pages7
JournalBiological and Pharmaceutical Bulletin
Volume38
Issue number10
DOIs
Publication statusPublished - 2015 Oct 1

Keywords

  • Abnormal behavior
  • Adverse event report
  • Oseltamivir

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

Fingerprint Dive into the research topics of 'Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports'. Together they form a unique fingerprint.

  • Cite this