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.
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.
Entities:
Keywords:
Japan; Pharmaceuticals and Medical Devices Agency; acute kidney injury; acyclovir; valacyclovir