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

Ueda, Norifumi; Umetsu, Ryogo; Abe, Junko; Kato, Yamato; Nakayama, Yôko; Kato, Zenichiro; Yasutomi, Keita; Nakamura, Mitsuhiro

doi:10.1248/bpb.b15-00253

Cited by 25 publications

(13 citation statements)

References 27 publications

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“…ROR was developed to detect drug-associated adverse events in the spontaneous reporting database 32 – 34 . To calculate the ROR, all reported adverse events associated with nephritis were defined as “cases” and all other reported adverse events as “non-cases”.…”

Section: Methodsmentioning

confidence: 99%

Renoprotective effects of a factor Xa inhibitor: fusion of basic research and a database analysis

Horinouchi

Ikeda

Fukushima

et al. 2018

Sci Rep

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Renal tubulointerstitial injury, an inflammation-associated condition, is a major cause of chronic kidney disease (CKD). Levels of activated factor X (FXa), a blood coagulation factor, are increased in various inflammatory diseases. Therefore, we investigated the protective effects of an FXa inhibitor against renal tubulointerstitial injury using unilateral ureteral obstruction (UUO) mice (a renal tubulointerstitial fibrosis model) and the Food and Drug Administration Adverse Events Reporting System (FAERS) database. The renal expression levels of FX and the FXa receptors protease-activated receptor (PAR)-1 and PAR-2 were significantly higher in UUO mice than in sham-operated mice. UUO-induced tubulointerstitial fibrosis and extracellular matrix expression were suppressed in UUO mice treated with the FXa inhibitor edoxaban. Additionally, edoxaban attenuated UUO-induced macrophage infiltration and inflammatory molecule upregulation. In an analysis of the FAERS database, there were significantly fewer reports of tubulointerstitial nephritis for patients treated with FXa inhibitors than for patients not treated with inhibitors. These results suggest that FXa inhibitors exert protective effects against CKD by inhibiting tubulointerstitial fibrosis.

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Section: Methodsmentioning

confidence: 99%

Renoprotective effects of a factor Xa inhibitor: fusion of basic research and a database analysis

Horinouchi

Ikeda

Fukushima

et al. 2018

Sci Rep

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“…Pharmacovigilance indexes, such as the ROR, have been developed to detect drug‐associated adverse events in the SRS, but these cannot be applied to evaluate the comparative strength of causalities (Bates & Evans, ). The ROR is a clear and easily applicable technique that allows for the control of covariates through logistic regression analysis (Abe et al., ; Suzuki et al., ; Ueda et al., ; Umetsu et al., ). An additional advantage of using the ROR is that non‐selective underreporting of a drug or adverse events has no influence on the value of the ROR compared with the population of patients experiencing an adverse event (Van der Heijden, van Puijenbroek, van Buuren, & van der Hofstede, ).…”

Section: Discussionmentioning

confidence: 99%

Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004–2015

et al. 2018

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AimPostpartum depression is a mood disorder that commonly affects women during the early postpartum period. The objective of this study was to analyse the association of postpartum depression with drugs (including contraceptive devices and implants) with spontaneously reported adverse events reported in the US Food and Drug Administration Adverse Event Reporting System database.DesignRetrospective study.MethodReports of postpartum depression events between 2004–2015 were analysed with a reporting odds ratio (ROR) algorithm. The Medical Dictionary for Regulatory Activities was used to identify postpartum depression.ResultsThe reporting odds ratios (95% confidence intervals, CI) of levonorgestrel (an intrauterine device with progestogen), etonogestrel (a hormonal contraceptive implant), sertraline and drospirenone (an oral contraceptive) were 12.5 (8.7–18.0), 14.0 (8.5–22.8), 12.2 (6.5–23.1) and 5.4 (2.7–10.9) respectively. Among the drugs in the US Food and Drug Administration Adverse Event Reporting System database, the use of contraceptives or an intrauterine device with progestogen might convey risk for postpartum depression.

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“…The FAERS database is subject to various biases such as under-reporting, over-reporting, exclusion of healthy individuals, and confounding by comorbidities [ 18 ]. The data subsetting strategy may help to mitigate the effect of confounding factors and bias on signal detection by limiting the analysis to a population of patients that are thought to share common risk factors and diseases [ 15 , 16 , 34 – 36 ].…”

Section: Discussionmentioning

confidence: 99%

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system

et al. 2017

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Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89–13.68), 6.43 (5.81–7.13), and 14.73 (11.42–18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74–9.07), 64.77 (56.84–73.80), and 28.76 (15.77–52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated-liposome DOX formulations.

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

Cited by 25 publications

References 27 publications

Renoprotective effects of a factor Xa inhibitor: fusion of basic research and a database analysis

Renoprotective effects of a factor Xa inhibitor: fusion of basic research and a database analysis

Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004–2015

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system

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