Safety assessment of tafamidis: a real-world adverse event analysis from the FAERS database.

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.