FDA gives strongest possible warning on anemia drug

The US Food and Drug Administration is strengthening the existing warning on Feraheme (ferumoxytol), manufactured by AMAG Pharmaceuticals (Nasdaq: AMAG).

Feraheme now carries the strongest type of FDA warning, a Boxed Warning, and advises that serious, potentially fatal allergic reactions can occur with the anemia drug. The FDA has also changed prescribing instructions, and added a new contraindication, for patients who have had an allergic reaction to any intravenous iron replacement product.

Health care professionals should follow the new recommendations in the drug label. Patients are told to seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash or itching during or after Feraheme administration.