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Valacyclovir-Induced Acute Kidney Injury in Japanese Patients Based on the PMDA Adverse Drug Reactions Reporting
Asuka Kitano1, Hideyuki Motohashi1, Akira Takayama1
11 Education and Research Center for Clinical Pharmacy, Kyoto Pharmaceutical University, Kyoto, Japan.
Background:
More than 250,000 reports of adverse drug events were included in the database of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. However, these data have not been utilized sufficiently for analysis. While valacyclovir is the antiviral agent used worldwide, it is reported to induce nephrotoxicity. The aim of this study was to clarify the profiles of valacyclovir-induced adverse events using the PMDA database.
Methods:
Case reports were screened in the PMDA adverse event database from 2004 to 2011. The profiles of patients with acute kidney injury (AKI) were analyzed by sex, age, diseases, concomitant suspected drugs, and outcomes.
Results:
A total of 514 kidney-related adverse events were detected, and 344 were cases that included AKI. Of the AKI cases, 246 patients (71.5%) were female. There were 145 patients who were 70 to 79 years of age, which was the most affected of all age groups. Of the 344 patients, 183 patients had hypertension, and 65 had diabetes. Valacyclovir was the only drug used among 257 patients (74.1%).
Conclusions:
There were many reports of AKI involving valacyclovir and females, particularly in the 70- to 79-year age group in Japan. The results suggest that these patients were most likely to develop AKI after valacyclovir treatment.
Insights
Valacyclovir can cause acute kidney injury (AKI), particularly in elderly females in Japan. This analysis of adverse event reports highlights a need for careful monitoring in at-risk populations.
Area of Science:
- Pharmacovigilance
- Nephrology
- Drug Safety
Background:
- The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) database contains over 250,000 adverse drug event reports.
- Valacyclovir, a widely used antiviral, is associated with nephrotoxicity.
- Insufficient utilization of existing adverse event data for analysis.
Purpose of the Study:
- To analyze adverse event profiles associated with valacyclovir using the PMDA database.
- To identify patient demographics and risk factors for valacyclovir-induced nephrotoxicity.
Main Methods:
- Screening of case reports in the PMDA adverse event database (2004-2011).
- Analysis of acute kidney injury (AKI) patient profiles, including sex, age, comorbidities, concomitant drugs, and outcomes.
Main Results:
- 514 kidney-related adverse events were identified; 344 involved AKI.
- Females constituted 71.5% of AKI cases.
- The 70-79 year age group was most affected.
- Hypertension and diabetes were common comorbidities.
- Valacyclovir was the sole suspected drug in 74.1% of AKI cases.
Conclusions:
- Valacyclovir is frequently associated with AKI reports in Japan.
- Elderly females (70-79 years) are a particularly high-risk group for valacyclovir-induced AKI.
- These findings underscore the importance of monitoring renal function in susceptible patients during valacyclovir therapy.
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