Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis. Periodic monitoring of laboratory parameters of iron storage may assist in recognition of iron accumulation. Ferrlecit® should not be administered in patients with iron overload.

Serum iron levels greater than 300 μg/dLmay indicate iron poisoning which is characterized by abdominal pain, diarrhea, or vomiting which progresses to pallor or cyanosis, lassitude, drowsiness, hyperventilation due to acidosis, and cardiovascular collapse. Caution should be exercised in interpreting serum iron levels in the 24 hours following the administration of Ferrlecit® since many laboratory assays will falsely overestimate serum or transferrin bound iron by measuring iron still bound to the Ferrlecit® complex. Additionally, in the assessment of iron overload, caution should be exercised in interpreting serum ferritin levels in the week following Ferrlecit® administration since, in clinical studies, serum ferritin exhibited a nonspecific rise which persisted for five days.

The Ferrlecit® iron complex is not dialyzable.

Ferrlecit® at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths to mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions. Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events based on information from postmarketing spontaneous reports. These adverse events included hypotension, nausea, vomiting, abdominal pain, diarrhea, dizziness, dyspnea, urticaria, chest pain, paresthesia, and peripheral swelling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• All anemias not associated with iron deficiency.
• Hypersensitivity to Ferrlecit® or any of its inactive components.
• Evidence of iron overload.

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