TY - JOUR
T1 - The risk of pulmonary adverse drug reactions of rebamipide and other drugs for acid-related diseases
T2 - An analysis of the national pharmacovigilance database in South Korea
AU - Yang, Bo Ram
AU - Lee, Jae Young
AU - Kim, Myeong Gyu
N1 - Funding Information:
The authors greatly appreciate the Korea Institute of Drug Safety & Risk Management (Ministry of Food and Drug Safety) for providing the KIDS‐KD for this study. This research was funded by National Research Foundation of Korea (no. NRF‐2021R1C1C1013177). KAERS database is available at the Korea Institute of Drug Safety ( https://open.drugsafe.or.kr/original/invitation.jsp ). The authors do not have any special access privileges to this data. The datasets used and/or analyzed during this study are not publicly available due to privacy or ethical restrictions.
Funding Information:
National Research Foundation of Korea, Grant/Award Number: NRF‐2021R1C1C1013177 Funding information
Funding Information:
The authors greatly appreciate the Korea Institute of Drug Safety & Risk Management (Ministry of Food and Drug Safety) for providing the KIDS-KD for this study. This research was funded by National Research Foundation of Korea (no. NRF-2021R1C1C1013177). KAERS database is available at the Korea Institute of Drug Safety (https://open.drugsafe.or.kr/original/invitation.jsp). The authors do not have any special access privileges to this data. The datasets used and/or analyzed during this study are not publicly available due to privacy or ethical restrictions.
Publisher Copyright:
© 2021 The Authors. Journal of Digestive Diseases published by Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.
PY - 2022/2
Y1 - 2022/2
N2 - Objective: The objective of this case/non-case study was to detect rebamipide-related pulmonary adverse events (AE) compared with other drugs for acid-related disorders based on population-level data. Methods: From 2009 to 2018, AE reports on drugs for acid-related disorders, which are anatomical therapeutic chemical code A02B drugs, in the Korea Adverse Events Reporting System (KAERS) database were examined. The reporting odds ratio (ROR) was calculated, and the odds of reporting pulmonary AE for rebamipide and all other A02B drugs were compared. Furthermore, a stratified analysis according to patients’ age and sex was conducted. Results: Altogether 13 (0.05%) and 157 (0.11%) cases of pulmonary AE were reported for rebamipide and all other A02B drugs, respectively. The risk of reporting pulmonary AE was significantly lower for rebamipide than for all other A02B drugs (ROR 0.49, 95% confidence interval [CI] 0.28–0.87). The number of reports of pulmonary AE for rebamipide was significantly higher among patients aged ≥65 years than those aged <65 years (ROR 19.36, 95% CI 2.50–149.97). Conclusions: Rebamipide was less often reported for pulmonary AE. However, healthcare professionals need to be aware of the risk of pulmonary AE in elderly patients.
AB - Objective: The objective of this case/non-case study was to detect rebamipide-related pulmonary adverse events (AE) compared with other drugs for acid-related disorders based on population-level data. Methods: From 2009 to 2018, AE reports on drugs for acid-related disorders, which are anatomical therapeutic chemical code A02B drugs, in the Korea Adverse Events Reporting System (KAERS) database were examined. The reporting odds ratio (ROR) was calculated, and the odds of reporting pulmonary AE for rebamipide and all other A02B drugs were compared. Furthermore, a stratified analysis according to patients’ age and sex was conducted. Results: Altogether 13 (0.05%) and 157 (0.11%) cases of pulmonary AE were reported for rebamipide and all other A02B drugs, respectively. The risk of reporting pulmonary AE was significantly lower for rebamipide than for all other A02B drugs (ROR 0.49, 95% confidence interval [CI] 0.28–0.87). The number of reports of pulmonary AE for rebamipide was significantly higher among patients aged ≥65 years than those aged <65 years (ROR 19.36, 95% CI 2.50–149.97). Conclusions: Rebamipide was less often reported for pulmonary AE. However, healthcare professionals need to be aware of the risk of pulmonary AE in elderly patients.
KW - KIDS KAERS database
KW - drug-related side effects and adverse reactions
KW - interstitial lung diseases
KW - pharmacovigilance
KW - rebamipide
UR - http://www.scopus.com/inward/record.url?scp=85124591508&partnerID=8YFLogxK
U2 - 10.1111/1751-2980.13075
DO - 10.1111/1751-2980.13075
M3 - Article
C2 - 34965009
AN - SCOPUS:85124591508
SN - 1751-2972
VL - 23
SP - 118
EP - 123
JO - Journal of Digestive Diseases
JF - Journal of Digestive Diseases
IS - 2
ER -