Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database

Abstract

Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database. Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter. Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and ≥ 3 anti-infectives were 8.88 (7.05−11.18), 9.77 (6.89−13.86), and 18.39 (11.85−28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of ≥ 70 years × 1 drug was 21.81 (14.56−32.68). Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC.

Analysis of drug-induced interstitial lung disease caused by herbal medicine using the Japanese Adverse Drug Event Report database

“…We used only reports with complete or calculable data on sex, age, and daily intake of each crude drug. The effectiveness of the explanatory variables was evaluated using a stepwise method with a significance level of 0.05 (forward and backward) [ 24 ]. We input the reporting year parameter into the following formula and evaluated the influence of the explanatory variable using the likelihood ratio test: …”

Association between anaphylaxis and anti-influenza drug use: An analysis of the Japanese Adverse Drug Event Report database

“…In recent years, studies have utilized data from the Japanese Adverse Drug Event Report (JADER) database, a national spontaneous reporting database in Japan (11)(12)(13), to investigate the association between adverse events and drugs. Therefore, in this study, data from the JADER database were used to analyze the association between anaphylaxis and anti-influenza drug use.…”

The Cytopathic Effect of Different Toxin Concentrations From Different Clostridioides difficile Sequence Types Strains in Vero Cells

“…Clostridioides difficile ( C. difficile ) is one of the most prevalent causes of nosocomial diarrhea. It is responsible for approximately 25% of antibiotic-associated diarrhea (AAD) infections and most events of pseudomembranous colitis associated with antibiotic use ( Nakao et al, 2020 ). During the last decade, the epidemiology of C. difficile infection (CDI) has changed, with increasing rates of incidence and recurrences.…”