- 著者
- Natsumi Ueda Ryogo Umetsu Junko Abe Yamato Kato Yoko Nakayama Zenichiro Kato Yasutomi Kinosada Mitsuhiro Nakamura
- 出版者
- 公益社団法人日本薬学会
- 雑誌
- Biological and Pharmaceutical Bulletin (ISSN:09186158)
- 巻号頁・発行日
- vol.38, no.10, pp.1638-1644, 2015-10-01 (Released:2015-10-01)
- 参考文献数
- 32
- 被引用文献数
- 2 23
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.
- 著者
- Ryogo Umetsu Junko Abe Natsumi Ueda Yamato Kato Toshinobu Matsui Yoko Nakayama Yasutomi Kinosada Mitsuhiro Nakamura
- 出版者
- 公益社団法人日本薬学会
- 雑誌
- Biological and Pharmaceutical Bulletin (ISSN:09186158)
- 巻号頁・発行日
- vol.38, no.11, pp.1689-1699, 2015-11-01 (Released:2015-11-01)
- 参考文献数
- 38
- 被引用文献数
- 1 23
Selective serotonin reuptake inhibitors (SSRIs) are prescribed for the treatment of depression worldwide. SSRIs are suspected to increase the risk of suicidal ideation and behavior (suicidality) in children, adolescents, and young adults. We examined the association between SSRI therapy and suicidality by applying a logistic regression model to age-stratified data from the Food and Drug Administration (FDA) Adverse Event Reporting System database. We attempted to mitigate the effect of patient-related factors by data subsetting. We selected case reports for SSRIs as referred to in the World Health Organization Anatomical Therapeutic Chemical classification code N06AB. The association between SSRIs and “suicidal events” or “self-harm events” was calculated as a reporting odds ratio (ROR) and adjusted for covariates by logistic regression. For subjects <18 years old (y.o.) the adjusted RORs (95% confidence interval) of SSRI therapy with suicidal events were 9.58 (8.97–10.23) in the whole data analysis and 4.64 (4.15–5.19) in the subset analysis; those with self-harm events were 31.40 (27.71–35.58) and 16.31 (13.12–20.29), respectively. Although the adjusted RORs were lower in the subset analyses than in the whole data analyses, both analyses indicated associations between SSRI treatment and suicidal and self-harm events. In both analyses these associations were stronger in the <18 y.o. group than other age groups. Children and adolescents should be closely monitored for the occurrence of suicidality when they are prescribed SSRIs. In addition, we found that data subsetting might mitigate the effect of an intrinsic risk among patients taking the suspected drug.