FERAHEME (Ferumoxytol) 30mg/mL injection by AMAG Pharmaceuticals
AMAG Pharmaceuticals has provided a safety update on Feraheme (ferumoxytol injection) indicating that serious adverse events have been reported at a rate consistent with that contained in the Prescribing Information. Of the estimated 35,000 patient exposures to date, 40 serious adverse events have been reported, an approximate rate of 0.1%. No mortality signal has been observed. A single reported death occurred in a patient two days post-Feraheme treatment, which AMAG does not believe was the result of Feraheme.
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.