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Safety assessment of tafamidis: a real-world adverse event analysis from the FAERS database
Min Chen1, Yaping Huang2, Chengjie Ke3,4
1Department of Orthopedics, Fujian Medical University Union Hospital, Fuzhou, China.
Background:
Tafamidis emerged as the first FDA-approved drug for treating termed amyloid fibrils. This study aims to analyze adverse events (AEs) related to tafamidis from the second quarter (Q2) of 2019 to the fourth quarter (Q4) of 2023 from the FDA adverse event reporting system (FAERS) database.
Research Design And Methods:
The AE data related to tafamidis from 2019 Q2 to 2023 Q4 were collected and standardized. Various signal quantification techniques, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for analysis.
Results:
Among the 8742 AE reports with tafamidis as the primary suspected drug, 180 preferred terms of AEs spanning 27 different system organ classes were identified. Unique adverse events to tafamidis included renal and urinary disorders and ear and labyrinth disorders, with not mentioned in the official drug label. Additionally, uncommon but significantly strong AE signals, such as blood culture positive and acquired hemophilia, were observed. Common AEs with relatively high occurrence rates included death, off-label use, fall, hypoacusis, and dysphagia.
Conclusion:
These findings offer valuable insights for optimizing the use of tafamidis and reducing potential side effects, thereby facilitating its safe use in clinical settings.
Insights
Tafamidis, the first drug for amyloid fibrils, showed unique adverse events like renal and ear disorders not on its label. This analysis of FDA data helps optimize its safe clinical use.
Area of Science:
- Pharmacovigilance
- Drug Safety Analysis
- Clinical Pharmacology
Background:
- Tafamidis is the first FDA-approved medication for treating transthyretin amyloidosis.
- Adverse events (AEs) associated with tafamidis require ongoing monitoring and analysis.
- The study focuses on AEs reported between Q2 2019 and Q4 2023.
Purpose of the Study:
- To analyze adverse events (AEs) linked to tafamidis.
- To identify unique and common safety signals from real-world data.
- To provide insights for optimizing tafamidis therapy and patient safety.
Main Methods:
- Utilized the FDA Adverse Event Reporting System (FAERS) database.
- Collected and standardized AE data from Q2 2019 to Q4 2023.
- Employed signal quantification techniques: ROR, PRR, BCPNN, and MGPS.
Main Results:
- Analyzed 8742 AE reports where tafamidis was the primary suspected drug.
- Identified 180 AE preferred terms across 27 system organ classes.
- Notable findings include unique AEs (renal, ear disorders) and significant signals (blood culture positive, acquired hemophilia), alongside common AEs (death, falls, hypoacusis).
Conclusions:
- Identified novel adverse events associated with tafamidis therapy.
- Highlighted common and uncommon adverse event signals.
- Findings support enhanced clinical monitoring and informed therapeutic strategies for tafamidis.
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