Abstract

Purpose: To evaluate the rate of adverse events associated with the use of intravenous sodium ferric gluconate in the ambulatory infusion center and to identify factors contributing to serious reactions.
Methods: This retrospective medication use evaluation included adult patients (18 years or older) who received sodium ferric gluconate infusions from January 1 to December 31, 2020. Adverse events within 48 hours of administration were reviewed and categorized as serious or non-serious. Serious events were further sub-classified as life-threatening or non-life-threatening. Descriptive statistics were used to assess patient demographics, dose, and outcomes.
Results: A total of 157 patients received 475 doses of sodium ferric gluconate. Thirty-one adverse events were reported, including 14 serious events among 13 patients (8%). All serious events occurred following the 250mg dose except for 1 at the 500mg dose. Most patients experiencing serious events were female (92%), with a high prevalence of other prior reported drug allergies (77%). The most common serious adverse event was hypotension (71%). Nine serious events required hospitalization, with a mean hospital stay of 16 hours. There were five life-threatening events (36%) in four unique patients.
Conclusion and relevance: The overall rate of serious adverse events was similar to previously reported rates, but the majority occurred at the 250mg dose. These findings prompted a formulary change at our institution to cap sodium ferric gluconate dosing at 125mg per administration. Continued pharmacovigilance and dose-specific monitoring are warranted to mitigate risk to patients.