AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company
focused on the development and commercialization of a therapeutic iron
compound to treat anemia and novel imaging agents to aid in the
diagnosis of cancer and cardiovascular disease, today provided a safety
update on Feraheme® (ferumoxytol) Injection for intravenous use.
Since the commercial launch of Feraheme in July 2009, serious
adverse events have been reported at a rate consistent with that
contained in the U.S. package insert. Of the estimated 35,000 patient
exposures to date, 40 serious adverse events have been reported, an
approximate rate of 0.1 percent. No mortality signal has been observed.
A single reported death occurred in a patient two days post-Feraheme
treatment, which the Company does not believe was the result of Feraheme.
Important Safety Information about Feraheme
Feraheme is indicated for the treatment of iron deficiency anemia
in adult patients with chronic kidney disease. Feraheme is
contraindicated in patients with evidence of iron overload, known
hypersensitivity to Feraheme or any of its components, and
patients with anemia not caused by iron deficiency.