Abstract
BACKGROUND
This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
METHODS
Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.
RESULTS
The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.
CONCLUSION
Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.
TY - JOUR
T1 - Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database.
AU - Yan,Liyuan,
AU - Zheng,Guanqun,
Y1 - 2024/11/03/
PY - 2025/3/14/medline
PY - 2024/10/30/pubmed
PY - 2024/10/29/entrez
KW - FAERS
KW - Non-infectious myocarditis
KW - data mining
KW - disproportionality analysis
KW - pharmacovigilance
SP - 345
EP - 353
JF - Expert opinion on drug safety
JO - Expert Opin Drug Saf
VL - 24
IS - 3
N2 - BACKGROUND: This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis. RESULTS: The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts. CONCLUSION: Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.
SN - 1744-764X
UR - https://www.unboundmedicine.com/prime/citation/39472113/Drug-induced_noninfectious_myocarditis:_a_disproportionality_analysis_of_the_FAERS_database.
DB - PRIME
DP - Unbound Medicine
ER -
