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FDA strengthens warning, changes prescribing instructions for Feraheme
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The FDA approved the addition of a boxed warning and updated the prescribing instructions for the anemia drug ferumoxytol, according to a press release from the agency.
The FDA strengthened an existing warning that serious, potentially fatal allergic reactions can occur with ferumoxytol (Feraheme, AMAG Pharmaceuticals). Since the drug’s approval for adults with chronic kidney disease who have iron-deficiency anemia in 2009, 79 cases of anaphylactic reactions occurred with ferumoxytol, 18 of which were fatal, according to data from the FDA. Forty-three percent of these patients had a medical history of drug allergy, and 24% had a history of multiple drug allergies.
The FDA also added a new contraindication for ferumoxytol, which strongly recommends patients who have had an allergic reaction to any IV iron replacement products avoid using ferumoxytol.
The boxed warning outlines these serious risks and recommends that health care professionals do the following:
- Administer IV iron products solely to patients who require IV iron therapy.
- Avoid administering ferumoxytol to patients with a history of allergic reactions to ferumoxytol or other IV iron products.
- Only administer diluted ferumoxytol to patients as an IV infusion over a minimum of 15 minutes. Do not administer ferumoxytol as an undiluted IV injection.
- Closely monitor patients for signs and symptoms of serious allergic reactions. Health care professionals should monitor blood pressure and pulse during ferumoxytol administration and for at least 30 minutes following every infusion.
- Carefully consider the potential risks and benefits of administering ferumoxytol to elderly patients with multiple or serious medical conditions, as older patients may experience more serious reactions.
- Carefully consider the potential risks and benefits of administering ferumoxytol to patients who have a history of multiple drug allergies, as these patients may be at a higher risk for more serious reactions.
The FDA encourages health care professionals and patients to report adverse events related to ferumoxytol to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.