Product News and Recalls

FDA Strengthens Warnings and Changes Prescription Instructions for Feraheme

feraheme given black box warning because of fatal allergic reactionsThe FDA announced in a Drug Safety Communication that it is strengthening warnings that the anemia drug Feraheme can lead to serious and sometimes fatal allergic reactions. The agency has also changed the prescribing instructions for Feraheme and added a Black Box Warning—the FDA’s strongest warning—to the drug’s packaging. The new warning strongly recommends against using Feraheme in any patient who has had an allergic reaction to intravenous (IV) iron replacement products in the past, and calls for monitoring patients, even those who have previously taken the drug.

Feraheme belongs to a class of medicines called IV iron replacement treatments. It is prescribed to help treat patients who suffer from iron-deficiency anemia. Patients with iron-deficiency anemia have a lower-than-normal number of blood red cells that carry oxygen throughout the body. Feraheme is used to replenish iron levels through an IV infusion. It is approved specifically for use only in adults with iron-deficiency anemia and patients with chronic kidney disease.

According to the FDA’s communication, all intravenous iron products pose a risk of potentially fatal allergic reactions. This much was indicated on Feraheme’s label when it was approved by the FDA in 2009. Since then, the drug has caused serious and sometimes deadly reactions, even when patients were treated immediately. To reduce the incidence of serious allergic reactions to Feraheme, the FDA has provided a Boxed Warning with updated prescription instructions recommending that health care professionals:

  • administer IV iron replacement products only to patients who require IV iron therapy;
  • not administer Feraheme to patients who have a history of allergic reactions to IV iron replacement products;
  • administer Feraheme only as a diluted IV infusion over a minimum of 15 minutes, and never as an undiluted injection;
  • closely monitor patients for signs and symptoms of serious allergic reactions;
  • carefully weigh the potential risks and benefits of administering Feraheme to elderly patients with multiple or serious medical conditions;
  • carefully weigh the potential risks and benefits of administering Feraheme to patients who have a history of multiple allergic reactions to any kinds of medications.

Always consult your doctor or health care provider whenever you decide to switch medications. If you or a loved one suffered a serious or fatal allergic reaction after using Feraheme, contact the pharmaceutical attorneys at Lopez McHugh for a free consultation. You may be eligible to receive compensation.