Evaluation of the Expression Time of Ganciclovir-Induced Adverse Events Using JADER and FAERS

• Published in: Biological & pharmaceutical bulletin Vol. 42; no. 11; pp. 1799 - 1804
• Main Authors: Ando, Go, Taguchi, Kazuaki, Enoki, Yuki, Yokoyama, Yuta, Kizu, Junko, Matsumoto, Kazuaki
• Format: Journal Article
• Language: English
• Published: Japan The Pharmaceutical Society of Japan 01.11.2019; Pharmaceutical Society of Japan; Japan Science and Technology Agency
• Subjects: Adverse Drug Reaction Reporting Systems; Antiviral drugs; Data Mining; database of spontaneous adverse event report; Databases, Factual; Datasets as Topic; Drug-Related Side Effects and Adverse Reactions - epidemiology; Ganciclovir; Ganciclovir - adverse effects; Humans; Japan; Leukopenia; Liver; Odds Ratio; Regulatory agencies; Renal failure; Side effects; Thrombocytopenia; United States; United States Food and Drug Administration; United States; Japan; data mining; ganciclovir; database of spontaneous adverse event report
• ISSN: 0918-6158; 1347-5215
• DOI: 10.1248/bpb.b19-00156

Investigation of the occurrence time of adverse drug reactions helps to prevent the development and aggravation of adverse reactions, but the expression time of ganciclovir-induced adverse events has not been elucidated. In this study, using databases of spontaneous adverse event reports, the Japanese Adverse Drug Event Report database (JADER) and the U.S. Food and Drug Administration (FDA)’s Adverse Event Reporting System (FAERS), the incidence of adverse reactions due to ganciclovir and their expression time were analyzed. As a result of calculation of the reporting odds ratio (ROR) and 95% confidence interval for individual main adverse reactions of ganciclovir (cytopenia, leukopenia, thrombocytopenia, liver damage, and acute renal failure), a signal was detected for all adverse reactions in both databases, except for liver damage in JADER. Furthermore, the Weibull distribution was performed for the analysis of onset time of each ganciclovir-induced adverse event. The results of Weibull parameter α and β values of each adverse event in both JADER and FAERS suggested that most adverse events occurred within 30 d and classified into the early failure type, except that thrombocytopenia and acute renal failure in JADER classified into the random failure type. Based on these findings, it concluded that the paying attention to signs of each ganciclovir-induced adverse event is required from the early phase after ganciclovir administration. However, in FAERS, development after a long-term course also accounted for 11%, suggesting that long-term periodic monitoring of adverse reactions would be also required.