(343) Identifying the Safety Signals for Adverse Events Causing Mortality Due to Ferric Carboxymaltose: A Disproportionality Analysis of Spontaneous Reports and Extensive Systematic Review

Background: Iron deficiency anemia (IDA) is a global health concern, with ferric
carboxymaltose (FCM) emerging as a preferred intravenous therapy for its efficacy and
safety profile. Recent reports of FCM-associated mortality necessitate a comprehensive
safety evaluation. This study aims to identify potential associations between FCM use and
fatal adverse events by analyzing spontaneous reports and conducting an extensive
systematic review.

Objectives: To Identifying the Safety Signals for Adverse Events Causing
Mortality Due to Ferric Carboxymaltose

Methods: We conducted a retrospective case/non-case study using spontaneous reports in
the FDA Adverse Event Reporting System (FAERS) from FDA approval to September 30,
2023. Disproportionality analysis was conducted by calculating the Proportional Reporting
Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) to identify
adverse event signals for FCM (PRR ≥ 2, LB ROR > 1, IC025 > 0). We systematically
searched electronic databases, including PubMed, Cochrane CENTRAL, Scopus, and
Google Scholar, from inception to December 31, 2023, to support the findings of
disproportionality analysis.

Results: There were 39 death cases reported in FAERS on FCM. However, no signal of
considerable strength was identified [PRR= 0.3 (χ2= 81.4), LB ROR= 0.2, IC025 = -2.4]. We
identified significant strength for AEs such as anaphylactic shock [PRR= 5.6 (χ2= 63.5), LB
ROR= 3.5, IC025 = 1.5], circulatory collapse [PRR= 15.0 (χ2= 455.5), LB ROR= 10.8, IC025
= 3.1], respiratory distress [PRR= 10.8 (χ2= 338.3), LB ROR= 7.9, IC025= 2.8], arrhythmia
[PRR= 3.5 (χ2= 45.2), LB ROR= 2.4, IC025= 1.1]. In the systematic review, we identified
the AEs such as anaphylactic reaction, severe hypophosphatemia, respiratory distress,
hypotension, bronchospasm, and hypophosphatemia osteomalacia.

Conclusions: Our study identifies potential safety signals associated with FCM, including
anaphylactic shock, circulatory collapse, respiratory distress, and arrhythmia. These
findings underscore the importance of informed decision-making and careful patient
selection when considering FCM therapy, emphasizing the need for heightened vigilance in
clinical practice.