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Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach
Author(s) -
Hosohata Keiko,
Inada Ayaka,
Oyama Saki,
Furushima Daisuke,
Yamada Hiroshi,
Iwanaga Kazunori
Publication year - 2019
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12748
Subject(s) - pharmacovigilance , medicine , acute kidney injury , odds ratio , adverse effect , adverse event reporting system , kidney disease , confidence interval , adverse drug reaction , intensive care medicine , database , pharmacology , drug , computer science
Summary What is known and objective Acute kidney injury ( AKI ) often occurs in hospitalized patients, and it is an increasing problem worldwide. Recently, clinical studies have shown that there is a strong association between drug‐induced AKI and poor outcomes, including the progression of chronic kidney disease and end‐stage renal disease; however, limited data are available on drug‐induced AKI . The purpose of this study was to clarify the rank‐order of the association of all drugs with AKI using a spontaneous reporting system database. Methods We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report ( JADER ) database. Adverse event reports submitted to Pharmaceuticals and Medical Devices Agency between April 2004 and January 2017 were analysed. Results and discussion Based on 5 195 890 reports of all adverse events, we obtained 12 964 reports of AKI caused by all drugs and calculated the reporting odds ratio ( ROR ) and 95% confidence interval ( CI ) for AKI . The most frequently reported drugs were valaciclovir hydrochloride ( ROR , 24.88; 95% CI : 23.1‐26.8), eldecalcitol ( ROR , 14.23; 95% CI , 11.68‐17.33), edaravone ( ROR , 14.03; 95% CI , 11.76‐16.75), acyclovir ( ROR , 11.17; 95% CI , 9.55‐13.1), piperacillin‐tazobactam ( ROR , 9.23; 95% CI , 7.72‐11.0), and spironolactone ( ROR , 7.36; 95% CI , 6.12‐8.86). What is new and conclusion A comprehensive study using a pharmacovigilance database enabled us to identify the drugs that most frequently induce AKI , raising physicians’ awareness of the drugs in use for patients with potentially decreased renal function.