Anemia Drug Feraheme Assigned Boxed Warning by FDA
The Food and Drug Administration has assigned a boxed warning – the highest level there is – for Feraheme (ferumoxytol), an anti-anemia drug. Feraheme has been found to increase the risk of “serious, potentially fatal allergic reactions” specifically for “patients who have had an allergic reaction to any intravenous (IV) iron replacement product” according to the FDA website. Symptoms of a reaction may include:
- Breathing problems
- Low blood pressure
- Lightheadedness
- Dizziness
- Swelling
- Rash
- Itching
The FDA states that “all IV iron products carry a risk of potentially life-threatening allergic reactions,” and that Feraheme was not originally found to be any more dangerous or risky than other similar drugs on the market. However, since its approval in 2009, Feraheme has been linked to serious allergic responses, some of which were fatal.
What is anemia?
Anemia is a condition where a person’s body does not make the right amount of red blood cells. Since red blood cells carry oxygen throughout the body, anemia can cause your organs to function poorly or inefficiently since they are not getting the right amount of oxygen. According to the latest numbers from the Centers for Disease Control and Prevention, about 237,000 people who visit the emergency room end up with a diagnosis of anemia each year.
One of the more common reasons why a person may have fewer red blood cells is deficient iron. Another is chronic kidney disease. The anemia could be the result of damaged kidneys not producing enough of a hormone called erythropoietin, which is what allows bone marrow to create red blood cells. CKD could also be exacerbated by low iron levels. Feraheme was prescribed to CKD patients with iron deficiency anemia.
Serous allergic reactions
Nephrology News & Issues reports rather startling statistics when it comes to Feraheme and allergic reactions. The FDA “Adverse Event Reporting System database identified 79 cases of anaphylactic reactions associated with Feraheme administration, reported from the time of approval to June 30, 2014. Of the 79 cases, 18 were fatal, despite immediate medical intervention and emergency resuscitation attempts.”
The research also shows:
- No visible pattern in regards to ages, as the patients were between 19 and 96
- One dose was enough to trigger nearly half of all cases of allergic reaction – and 60 people said their reaction started while the infusion was taking place or within 5 minutes of it ending
- 34 people had a drug allergy in their medical files
- 24% of patients had multiple drug allergies
- “Cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing” were among the symptoms
If you or your loved one has experienced a severe allergic reaction while taking Feraheme, Paulson & Nace, PLLC may be able to help. Please contact our Washington, D.C. medical malpractice firm to find out about our legal services and practices.
Christopher T. Nace works in all practice areas of the firm, including medical malpractice, birth injury, drug and product liability, motor vehicle accidents, wrongful death, and other negligence and personal injury matters.
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