The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug “Feraheme”. It could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product. Health care professionals should strictly follow the recommendations mentioned in the drug label. Patients should immediately call doctor if there is breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
Feraheme (ferumoxytol) is a type of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen. Feraheme is used to treat iron deficiency anemia in people with chronic kidney disease. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease. It is given as an IV infusion . Anemia is a lack of red blood cells caused by having too little iron in the body.
FDA found 79 anaphylactic reactions in its Adverse Event Reporting System between June 2009 and June 30, 2014. The patients were aged 19 to 96 years. Half of the reactions occurred with the first dose, and three-quarters began during infusion or within 5 minutes of completion. Eighteen of the 79 patients died despite immediate medical intervention and emergency resuscitation attempts.
Based on our evaluation, label information were updated, adding a Boxed Warning so that Potential adverse events can be reduced
· Administer IV iron products only to patients who require IV iron therapy.
- Do not prescribe Feraheme to patients having history of allergic reaction to Feraheme or other IV iron products.
- Only administer diluted Feraheme as an IV infusion over a minimum of 15 minutes. And do not recommend Feraheme as an undiluted IV injection.
- Strictly monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during Feraheme administration and for at least 30 minutes following each infusion.
- Carefully monitor the potential risks and benefits of Feraheme administration in elderly patients with multiple or serious medical conditions, as these patients may experience more severe reactions.
- Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.
