Safety of deferasirox: A retrospective cohort study on the risks of gastrointestinal, liver and renal events

Weng Foung Huang, Hsin Chun Chou, Yi Wen Tsai, Fei Yuan Hsiao*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


Background: Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. Methods: To examine the risks of gastrointestinal (GI) bleeding, acute liver necrosis, and acute renal failure among DFX users compared with desferrioxamine (DFO) users in a real-world setting, first-time users of DFX or DFO between 2005 and 2008 in Taiwan's National Health Insurance database were observed in this population-based retrospective cohort study. The risks of different adverse events were individually analyzed by Cox proportional hazards models and adjusted by age, sex, concomitant medications, and prior medical conditions. Results: Deferasirox users had the highest incidence rates of GI bleeding (2.03 per 10000 patient-days), acute liver necrosis (0.26 per 10000 patient-days) and acute renal failure (1.45 per 10000 patient-days) compared with other iron chelator users. Compared with DFO users, DFX users were not associated with the risk of GI bleeding (adjusted HR 1.03, 95% CI 0.61-1.74, p=0.90) and the risk of acute liver necrosis (adjusted HR 2.13, 95% CI 0.49-9.33, p=0.32). The association between DFX use and acute renal failure was found to be statistically significant (HR 2.18, 95% CI 1.18-4.02, p=0.01; adjusted HR 2.41, 95% CI 1.27-4.58, p=0.01). Conclusion: In this study, we found statistically significant higher risk of acute renal failure and non-statistically significant higher risk of GI bleeding and acute liver necrosis associated with DFX use. More researches are warranted to evaluate the association between DFX use and potential adverse events.

Original languageEnglish
Pages (from-to)1176-1182
Number of pages7
JournalPharmacoepidemiology and Drug Safety
Issue number11
StatePublished - 1 Nov 2014


  • Acute liver necrosis
  • Acute renal failure
  • Deferasirox
  • Desferrioxamine
  • Gastrointestinal bleeding
  • Iron chelator
  • Pharmacoepidemiology


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