What is Injectafer?
Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients. The U.S. Food and Drug Administration (FDA) approved Injectafer in July 2013. Two doses are administered intravenously by a doctor at least 7 days apart. Injectafer is manufactured by American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals Inc.
What is Iron Deficiency Anemia?
Iron deficiency anemia occurs when the blood lacks adequate healthy red blood cells due to insufficient iron, according to Adult Family Physician. Iron deficiency is the most common nutritional disorder worldwide and accounts for nearly 50% of anemia cases. The diagnosis of iron deficiency anemia is confirmed by the findings of low iron stores and a hemoglobin level 2 standard deviations below normal.
What’s the Problem?
Multiple peer-reviewed studies have found that ferric carboxymaltose, the type of iron contained in Injectafer, increases the risk for hypophosphatemia, or HPP, compared to other similar medications. Our class action lawyers are reviewing potential lawsuits against manufacturers for failure to warn about this dangerous and potentially deadly Injectafer side effect.
What is Hypophosphatemia?
Hypophosphatemia is a medical condition characterized by abnormally low levels of phosphate in the blood, according to Merck Manuals. Phosphate is an electrolyte that helps the body with energy production and nerve function. Hypophosphatemia may present as acute (coming on quickly), or chronic (developing over time).
- Muscle weakness
- Osteomalacia (softening of the bones)
- Serious neuromuscular disturbances
- Progressive encephalopathy (brain damage)
Note: Hypophosphatemia may be asymptomatic in some patients.
Injectafer Medical Studies
Research going back to 2013 has linked ferric carboxymaltose (the active ingredient in Injectafer) to increased rates of hypophosphatemia. In 2015, a study published in the International Journal of Rheumatology looked at data on 52 patients who received iron sucrose injections, and 78 patients who received FCM injections. The researchers found that only 22% of those treated with iron sucrose developed HPP, while 51% of those treated with FCM developed HPP, including 13% with severe HPP. “Hypophosphatemia is frequent after parenteral FCM injection and may have clinical consequences, including persistent fatigue,” the authors concluded.
In 2016, a study in PLOS One found that 45.5% of patients who were injected with FCM were diagnosed with HPP, and 32% developed severe HPP, compared to just 4% HPP and 0% severe HPP with iron isomaltoside (IIM), a different injectable iron supplement. The researchers concluded that treatment with ferric carboxymaltose “is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.”
Injectafer Side Effects
- Serious allergic reactions
- Low blood pressure
- Loss of consciousness
- High blood pressure
- Facial flushing
- And more
Patients with suspected hypophosphatemia should have a blood test to check whether they have high phosphate levels. If the patient’s kidneys are damaged, they can lower high blood phosphate levels in 3 ways:
- Quitting Injectafer
- Reducing the amount of dietary phosphate
- Removing extra phosphate with dialysis
- Lowering the amount of phosphate the intestines absorb using medication
Do I Have an Injectafer Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Injectafer Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was diagnosed with hypophosphatemia after taking Injectafer, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.