Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database

Area of Science:

• Gastroenterology
• Pharmacovigilance
• Epidemiology

Background:

• Microscopic colitis (MC) is a chronic inflammatory bowel disease presenting with watery diarrhea.
• Epidemiological data on MC in Japan is limited compared to Western countries.
• Understanding factors associated with MC is crucial for diagnosis and management.

Purpose of the Study:

• To investigate potential associations between drug use and microscopic colitis in Japan.
• To generate hypotheses regarding factors contributing to MC development using real-world data.

Main Methods:

• Analysis of the Japanese Adverse Drug Event Report (JADER) database from 2004 to 2021.
• Inclusion of 161 cases of microscopic colitis (MC) out of 246,997 total reports.
• Application of Weibull analysis for onset duration and logistic regression for association analysis.

Main Results:

• MC was significantly associated with female sex, age ≥ 60 years, and use of lansoprazole, aspirin, and nicorandil.
• Median onset duration for MC was 72.5 days for lansoprazole and 116.0 days for aspirin users.
• Obesity showed a positive association with MC in female cases.

Conclusions:

• The study suggests potential associations between microscopic colitis and the drugs lansoprazole, aspirin, and nicorandil.
• Findings highlight specific demographic factors (female sex, age ≥ 60) and obesity as potentially relevant.
• While causality cannot be inferred, these associations warrant further investigation.