Infectafer is an injectable iron complex used to treat iron deficiency anemia (IDA) in adult patients who cannot take iron supplements or had a poor response to them and adult patients with chronic kidney disease who are not receiving dialysis.
The manufacturer, American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc., does not warn about the serious risk posed by Injectafer, leaving patients and doctors unaware of the danger.
Injectafer Increases Risk of Severe Hypophosphatemia (HPP)
HPP is a condition in which blood levels of phosphate become abnormally low. Severe HPP is the most serious and dangerous type of HPP and can cause symptoms like seizures, muscle wasting, respiratory failure, acute hemolytic anemia (in which red blood cells are destroyed), and fatal arrhythmias. Studies have shown that severe HPP can increase mortality (death) by four-fold.
Researchers reported in 2016 that among patients injected with ferric carboxymaltose (FCM), the type of iron used in Injectafer, the prevalence of HPP was 45.5% and the prevalence of severe HPP was 32% as compared to only 4% HPP and no severe HPP with another form of injectable iron supplement, iron isomaltoside (IIM). Other studies have shown similar results, but so far, American Regent has failed to provide adequate warnings on Injectafer, stating only that the injection may result in mild side effects like headaches, nausea, and “low levels of phosphorus in the blood.” These warnings do not reveal the potentially dangerous and even deadly risk of severe HPP.
If left untreated, severe HPP may result in:
- Rhabdomyolysis (muscle wasting)
- Muscle pain
- Respiratory failure
- Heart failure
- Acute hemolytic anemia (a condition in which red blood cells are destroyed too quickly)
- Fatal arrhythmias (heart rhythm abnormalities)
- Bone pain and fractures
Chaffin Luhana is investigating cases involving patients who suffered injuries because of Injectafer. If you or a loved one went through treatment with Injectafer and experienced serious side effects such as those listed above, you may be eligible to file an Injectafer lawsuit to recover damages.
What Is Injectafer?
Released on the U.S. market in 2013, Injectafer is an injectable form of ferric carboxymaltose (FCM), an iron complex that consists of a ferric hydroxide core (a form of iron) stabilized by a carbohydrate shell.
Injectafer is delivered directly to the bloodstream, providing up to 1,500 mg in just two administrations separated by at least seven days. Once in the blood, it is designed to gradually release iron to decrease the symptoms of iron deficiency anemia.
Injectafer is the fastest growing form of intravenous iron in the U.S., but recent research has raised significant concerns about its safety. Clinical studies involving Injectafer indicate that the product increases the risk of HPP and severe HPP at rates higher than other alternative iron supplements.
What Is Adult Iron Deficiency Anemia?
Adult iron deficiency anemia is a condition in which low levels of iron in the blood result in a decreased production of hemoglobin. Hemoglobin is the part of red blood cells that transports oxygen throughout the body and delivers it to the organs and cells that need it. Without enough hemoglobin in the body, these cells and organs become deprived of oxygen and cannot function normally.
Symptoms of iron deficiency anemia include excessive fatigue, pale skin, muscle weakness, cold hands and feet, shortness of breath, and lightheadedness, and unusual cravings for things like dirt and ice.
The causes of IDA are various and include blood loss, a lack of iron in the diet, an inability to absorb iron, and pregnancy. Individuals with greater risk for the disorder include women, infants and children, vegetarians, frequent blood donors, and people with digestive disorders like celiac disease and Crohn’s disease.
How Is Adult Iron Deficiency Anemia Treated?
IDA is often treated with oral iron supplements. Within three months or more, iron levels are usually restored to normal. In some cases, however, the supplements fail to increase blood-iron levels as expected. This may be because the patient can’t absorb the iron from the supplements or because the patient can’t tolerate consistent iron supplements, typically due to digestive problems. These patients are often deemed candidates for injectable iron.
What Is Hypophosphatemia (HPP)?
HPP is a condition in which blood levels of phosphate become abnormally low, to the point of causing symptoms and potential complications. Phosphate is a combination of phosphorous and oxygen.
When you eat certain foods containing phosphorus, like milk, eggs, meat, and beans, phosphorus enters the digestive system, meets up with oxygen, and becomes phosphate. Most of that phosphate then teams up with calcium to repair bones and teeth, while some moves on to support healthy muscles and nerves.
When phosphate levels drop, as is the case in people with HPP, the body no longer has the raw material it needs to maintain normal body functioning. HPP can be mild to severe with HPP symptoms becoming worse the lower phosphate levels become and the longer they stay low.
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Clinical Studies Link Injectafer Use with an Increased Incidence of Hypophosphatemia (HPP) and Severe Hypophosphatemia
Clinical studies have indicated that Injectafer increases the risk of HPP. In 2016, researchers in Austria compared the rate of HPP in patients injected with FCM, the type of iron used in Injectafer, to patients injected with iron isomaltoside, another iron supplement used to treat iron deficiency anemia.
Among the 81 subjects in the Austrian study, researchers found that the risk of HPP was greater after an injection of FCM than with iron isomaltoside. More specifically, in those injected with FCM, the prevalence of HPP was 45.5%, and the prevalence of severe HPP was 32.7%. For IIM, the rate of HPP was only 4% and the number of cases of severe HPP with IIM was 0.
Further, the researchers observed that severe hypophosphatemia, in which phosphate levels are extremely low (<0.6 mmol/L), occurred only in patients using ferric carboxymaltose. The median time with HPP was around 41 days, but some patients, HPP was prolonged two months or longer.
Researchers concluded that treatment with FCM “is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.” The authors of the study added that the risk was “substantially lower” with IIM.
A 2015 study involving medical data from 52 patients who received iron sucrose injections and 78 patients who received FCM injections showed 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,” the researchers wrote, “and may have clinical consequences, including persistent fatigue.”
In a 2017 letter to the editor, doctors revealed that HPP had been described to occur in up to 70% of patients treated with FCM. Researchers again noted in a 2017 study that results from clinical trials suggested a higher risk for HPP with certain types of iron injections, including FCM. And, in a study published as early as 2013, researchers found that FCM lowered phosphate levels, with the effects persisting for three months.
If you or a loved one was treated with Injectafer and experienced severe HPP or other serious side effects such as those listed above, you may be eligible to file an Injectafer lawsuit. Chaffin Luhana will work to help you receive the compensation you deserve. Call today at 1-888-480-1123 or complete our case review form.