FDA Issues Strong Warning on Anemia Drug Risks

The FDA has issued a Boxed Warning for the anemia treatment, ferumoxytol (Feraheme), to alert patients and health care professionals about the potentially fatal allergic reactions that may occur with the drug’s use.

Intravenous (IV) iron replacement products such as Feraheme all carry a risk of potentially life-threatening allergic reactions, requiring them to be administered in a health care setting where emergency personnel and equipment are available to immediately treat any possible reaction. According to an FDA press release, Feraheme has been responsible for a number of serious reactions and deaths since its 2009 approval, prompting the need for a strengthened warning.

The new Boxed Warning will include the following instructions and recommendations:

• Only administer IV iron products to patients who require IV iron therapy.
• Do not administer Feraheme to patients with a 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. Feraheme should not be given as an undiluted IV injection.
• Closely 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 consider 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.

The FDA recommend that patients immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.

In addition to contacting their health care professionals, patients who have experienced adverse reactions to the affected product should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.