Feraheme Avoids Black-Box Warning

Although Amag Pharmaceuticals has come under scrutiny by the Food and Drug Administration (FDA), the company has managed to avoid a black-box on their popular iron deficiency anemia drug, Feraheme (ferumoxytol).

Feraheme is an injectable drug designed to treat iron deficiency anemia in patients with chronic kidney disease. The drug has been known to cause hypersensitivity reactions, including anaphylaxis and/or anaphylactoid reactions. According to drugs.com, in clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. Other reactions include hypotension (1.9% of subjects) and iron overload.

Although Feraheme will avoid the FDA’s black-box warning, the drug label is now required to include bolded warnings and precautions that describe adverse events that have been reported following Feraheme use. According to the Boston Business Journal, the label will also instruct health care providers to increase the observation period following Feraheme administration from 30 to 60 minutes to observe patients for signs and symptoms of hypersensitivity.

"We are pleased to have reached resolution with the Agency and have this uncertainty behind us," Brian J.G. Pereira, M.D., president and chief executive officer of Amag, said in a statement.