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Vonoprazan-associated Microscopic Colitis and Continued Use After Onset: A Study Using a Japanese Pharmacovigilance
Kota Nakanishi1, Yuichi Uwai2, Tomohiro Nabekura1
1School of Pharmacy, Aichi Gakuin University, Nagoya, Japan.
Background/Aim:
Microscopic colitis is a known side-effect of proton pump inhibitors, but its association with the potassium-competitive acid blocker vonoprazan remains unclear. This study investigated this relationship, including the continued administration of vonoprazan after colitis onset.
Patients And Methods:
Data from the first quarter of 2004 until the first quarter of 2024 in the Japanese Adverse Drug Event Report (JADER) database were analyzed. The reporting odds ratio (ROR) with its 95% confidence interval (CI) was calculated, and logistic regression analyses were performed. The proportion of patients with continued administration after onset was compared using Fisher's exact test with Bonferroni correction, and the administration duration was analyzed using the Steel-Dwass test.
Results:
Among 1,523,914 adverse drug event reports from 921,160 cases, 751 reports of microscopic colitis were identified. Lansoprazole was the suspected cause in 481 reports (ROR=362, 95% CI=311-421), whereas vonoprazan appeared in 55 reports (ROR=33.5, 95% CI=25.4-44.1). Univariate and multivariate analyses yielded adjusted ORs of 2.56 (95% CI=2.23-2.93) and 2.87 (95% CI=2.48-3.31), respectively, for the association between vonoprazan and microscopic colitis. The time to onset of microscopic colitis in vonoprazan users ranged from 7 to 731 days (median=31 days). The proportion of reports in which lansoprazole and vonoprazan were continued after microscopic colitis onset was higher than that of vonoprazan continuation after drug eruption (i.e. adverse cutaneous reactions). The duration of continued administration after microscopic colitis onset was longer than that after drug eruption.
Conclusion:
Using the JADER database, this study identified a safety signal for microscopic colitis associated with vonoprazan which is not listed in its package insert. Patients might continue vonoprazan after the onset of microscopic colitis. Although the database relies on spontaneous reporting, these findings warrant further investigation.
Insights
This study found a potential link between vonoprazan and microscopic colitis, a side effect not listed in its labeling. Patients may continue vonoprazan even after developing colitis symptoms.
Area of Science:
- Gastroenterology
- Pharmacovigilance
- Drug Safety
Background:
- Microscopic colitis is a known side effect of proton pump inhibitors.
- The association between vonoprazan, a potassium-competitive acid blocker, and microscopic colitis is not well-established.
- Investigating potential drug-induced gastrointestinal adverse events is crucial for patient safety.
Purpose of the Study:
- To investigate the association between vonoprazan use and microscopic colitis.
- To assess the continued use of vonoprazan after the onset of microscopic colitis.
- To compare the safety profile of vonoprazan with lansoprazole regarding microscopic colitis.
Main Methods:
- Analysis of the Japanese Adverse Drug Event Report (JADER) database from 2004 to 2024.
- Calculation of reporting odds ratios (ROR) and logistic regression for association.
- Comparison of drug continuation rates and durations using Fisher's exact test and Steel-Dwass test.
Main Results:
- A safety signal for microscopic colitis associated with vonoprazan was identified (ROR=33.5).
- Adjusted odds ratios indicated a significant association between vonoprazan and microscopic colitis (aOR=2.87).
- The median time to onset for vonoprazan-induced microscopic colitis was 31 days, with continued use observed post-diagnosis.
Conclusions:
- Vonoprazan is associated with a risk of microscopic colitis, a finding not currently in its package insert.
- Continued vonoprazan administration after microscopic colitis onset was noted.
- Further research is warranted to confirm these findings, despite reliance on spontaneous reporting.
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