Safety Summary | Adverse Events
The Drive Study
 
 

Ferrlecit® therapy was safe and well tolerated.

No treatment-related serious adverse events were reported in Ferrlecit®-treated patients.
Adverse events occurring in more than 5% of patients were diarrhea (7.6%), hypertension (7.6%), and hypotension (6.1%) in the control group and diarrhea (6.1%) in the IV iron group.

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Key Findings2

  Increase in serum ferritin was 173 ng/mL, which was consistent with previous studies.6,7

  Ferrlecit® therapy did not exacerbate existing inflammation as suggested by a lack of increase in median CRP.

  Ferrlecit® therapy was safe and well tolerated in this population, with no treatment-related serious adverse events reported.

 
 

*Study was not powered for safety

Important Safety Information3

Ferrlecit® is indicated for the treatment of iron deficiency anemia in chronic hemodialysis patients age 6 years and over receiving supplemental epoetin therapy • Ferrlecit® is contraindicated in non iron-deficient anemias, in patients hypersensitive to Ferrlecit® or its inactive components, or with evidence of iron overload • Hypersensitivity reactions have been reported with injectable iron products • Hypotension has been reported with rapid administration of IV iron • In a single-dose, placebo-controlled safety study (n=1097), the most frequent adverse events occurring after Ferrlecit® administration were hypotension, nausea, and vomiting and/or diarrhea • In multiple-dose studies (n=126), the most frequent adverse events, whether or not related to Ferrlecit® administration were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps, hypertension, dizziness, dyspnea, and chest pain