Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source

Y Noguchi, T Tachi, H Teramachi - Briefings in bioinformatics, 2021 - academic.oup.com
Continuous evaluation of drug safety is needed following approval to determine adverse
events (AEs) in patient populations with diverse backgrounds. Spontaneous reporting …

Safety of antipsychotic drugs: a systematic review of disproportionality analysis studies

D Cepaityte, S Siafis, G Papazisis - Behavioural Brain Research, 2021 - Elsevier
Antipsychotic drugs are commonly prescribed, mainly for the treatment of schizophrenia and
other psychotic disorders. Disproportionality analysis of pharmacovigilance data from …

High hepatic and plasma exposures of atorvastatin in subjects harboring impaired cytochrome P450 3A4∗ 16 modeled after virtual administrations and possibly …

K Adachi, K Ohyama, Y Tanaka, T Sato… - Drug Metabolism and …, 2023 - Elsevier
Drug interactions between atorvastatin and cytochrome P450 (P450) 3A
substrates/inhibitors lead to an increased incidence of skeletal muscle or hepatic toxicity …

Analysis of clozapine-induced seizures using the Japanese Adverse Drug Event Report database

M Hatano, K Yamada, H Matsuzaki, R Yokoi, T Saito… - PloS one, 2023 - journals.plos.org
Among antipsychotics, clozapine is associated with a high risk of seizures. This study aimed
to generate novel hypotheses regarding trends in the onset of clozapine-induced seizures …

Plasma and hepatic exposures of celecoxib and diclofenac prescribed alone in patients with cytochrome P450 2C9* 3 modeled after virtual oral administrations and …

K Adachi, K Ohyama, Y Tanaka, H Nakano… - Biological and …, 2023 - jstage.jst.go.jp
The impacts of polymorphic cytochrome P450 (P450 or CYP) 2C9 on drug interactions and
the pharmacokinetics of cyclooxygenase inhibitors have attracted considerable attention. In …

The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade

M Tsuchiya, T Obara, M Miyazaki, A Noda… - International Journal of …, 2020 - Springer
Background The quality of adverse drug reaction reports can have a strong influence on the
causality assessment or the detection of safety signals. Various methods have been used to …

Potential safety signal of pregnancy loss with vascular endothelial growth factor inhibitor intraocular injection: A disproportionality analysis using the Food and Drug …

T Sakai, C Mori, F Ohtsu - Frontiers in Pharmacology, 2022 - frontiersin.org
Objectives: Intraocular administration of vascular endothelial growth factor (VEGF) inhibitors
may be associated with pregnancy loss. However, little is known about intraocular anti …

A real-world disproportionality analysis of cyclosporine from the FDA Adverse Event Reporting System (FAERS) database

S Cui, L Li, W Liu, B Zhao, X Zhong - Brazilian Journal of Medical and …, 2024 - SciELO Brasil
Cyclosporine is an immunosuppressant used to prevent organ rejection in kidney, liver, and
heart allogeneic transplants. This study aimed to assess the safety of cyclosporine through …

Impact of adverse events on patient outcomes in a Japanese intensive care unit: a retrospective observational study

G Aikawa, A Ouchi, H Sakuramoto, C Ono… - Nursing …, 2021 - Wiley Online Library
Aim We investigated adverse events (AEs) in a Japanese intensive care unit (ICU) and
evaluated the impact of cause‐specific AEs on mortality and length of stay. Design A …

Estimating culprit drugs for adverse drug reactions based on Bayesian inference

K Hamada, T Abe, K Kouda, M Nakatsui… - Clinical …, 2023 - Wiley Online Library
The utility of big data in spontaneous adverse drug reactions (ADRs) reporting systems has
improved the pharmacovigilance process. However, identifying culprit drugs in ADRs …