Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting Database.

BACKGROUND: Telaprevir is a protease inhibitor currently used in the treatment of chronic hepatitis C virus (HCV) infection. One of its adverse effects is renal impairment. The Pharmaceutical and Medical Device Agency (PMDA) in Japan reported on telaprevir-related renal dysfunction in 2012. In this study, renal adverse events of telaprevir were investigated using the Japanese Adverse Drug Event Report database. Patient profiles with adverse events might provide useful information for HCV therapy. METHODS: We screened the case reports in Japanese Adverse Drug Event Report database (JADER) of the PMDA. The profiles of patients with renal adverse events were analyzed. RESULTS: The present results showed that reports of renal adverse events were most common in male patients between 60 and 69 years of age. Significant factors that affect the clinical outcomes of renal adverse events were not detected. However, it was suggested that anorexia is associated with renal adverse events. CONCLUSIONS: The number of reports of renal adverse events were highest in male patients 60 to 69 years of age treated with telaprevir. In addition, our findings suggested that anorexia is correlated with renal adverse events after telaprevir treatment. Further investigation is required to clarify the mechanism of renal impairments during triple therapy. Such knowledge might improve the safety of telaprevir therapy.

Valacyclovir-Induced Acute Kidney Injury in Japanese Patients Based on the PMDA Adverse Drug Reactions Reporting Database.

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.