In 2013, the FDA approved the iron supplement Injectafer. This drug is used to treat iron-deficiency anemia, a condition where the body lacks enough iron to produce healthy red blood cells. Shortly after FDA approval, studies revealed that the use of Inectafer could cause severe hypophosphatemia (HPP) in some patients.
As a result, several Injectafer lawsuits have been filed against its manufacturers and distributors. The plaintiffs in these suits allege that the drug caused their severe hypophosphatemia, a condition where the body experiences low phosphate levels. Our law firm is currently accepting new Injectafer lawsuits.
Injectafer is the brand name for ferric carboxymaltose, an iron supplement used to treat iron-deficiency anemia. Iron deficiency anemia is a condition in which abnormally low iron levels in the body result in the lack of healthy red blood cells. Injactafer is like injectable iron. It is administered in single 750 mg doses. A single course comprises two doses administered seven days apart. Injectafer is primarily for anemic patients who neither tolerate oral iron supplements nor find them effective. It can also treat iron deficiency anemia in non-dialysis chronic kidney disease patients.
Swiss-based Vifor Pharmaceuticals manufactures Injectafer. It is sold abroad under the brand name Ferinject. American Regent, formerly named Luitpold Pharmaceuticals, distributes it in the United States. This company is a subsidiary of the Japanese pharmaceutical giant Daiichi Sankyo. The FDA approved Injectafer on July 25, 2013. Over 800,000 U.S. patients take this medication.
Injectafer Side Effects
Common Injectafer side effects include the following:
- Severe allergic reactions including itching, rashes, hives, wheezing, shock, low blood pressure, lost consciousness, and death.
- High blood pressure
- Facial flushing
- Breathing difficulties
- Severe hypophosphatemia
- Elevated liver enzymes
- Hemosiderin staining
- Injection site pain or bruising
- Iron overload
FDA Approval of Injectafer
In July 2006, Luitpold Pharmaceuticals sent a New Drug Application (NDA) for Injectafer to the FDA. The agency rejected it. It found that this injectable iron increased the risk of death, severe adverse effects, and severe hypophosphatemia. In 2011, submitted another NDA. The FDA rejected it because of manufacturing concerns. In 2013, Luitpold resubmitted the NDA. This time, the FDA approved it.
Studies Linking Injectafer to Hypophosphatemia
There have been a number of published studies that underscore the concern with Injectafer.
2015 International Journal of Rheumatology Study
In a Belgian study from April 27, 2015, researchers tested two intravenous iron drugs’ association with hypophosphatemia. They examined medical records from a Belgian hospital. The researchers narrowed their data to 78 Ferinject (Injactafer) patients and 52 Venofer patients. They found that 51 percent of Ferinject patients suffered hypophosphatemia, 13 percent of which experienced severe symptoms. Only 22 percent of Venofer patients experienced hypophosphatemia. The researchers concluded that Ferinject was more likely to cause severe HPP than Venofer.
2016 Austrian Study
An Austrian study, published on December 1, 2016, also looked at the association between two intravenous iron drugs and hypophosphatemia. Instead of Venofer, the researchers looked at Monofer. Their data came from an Austrian hospital’s medical records. They narrowed it down to 55 Ferinject patients and 26 Monofer patients. The researchers found that eight Ferinject patients and one Monofer patient had pre-existing hypophosphatemia. None of them had severe symptoms. Following administration, 19 additional Ferinject patients and one additional Monofer patient developed hypophosphatemia. All 16 patients with severe symptoms exclusively took Ferinject. The researchers concluded Ferinject was associated with severe HPP compared to Monofer.
2018 Journal of Clinical Investigation
In an AMAG Pharmaceuticals-sponsored study, researchers tested intravenous iron drugs’ association with hypophosphatemia. They recruited approximately 2,000 patients from the United States, Canada, and Europe. The researchers administered Injectafer to half the group and Feraheme to the other half. After two weeks, 49 percent of Injectafer patients experienced hypophosphatemia.
By contrast, and this is the key, only one percent of Feraheme patients developed this condition. After five weeks, 29 percent of Injectafer patients continued to experience hypophosphatemia. None of the Feraheme patients experienced it in the same period. The researchers concluded Injectafer was more likely to cause hypophosphatemia than Feraheme.
2019 Alimentary Pharmacology and Therapeutics
A Norwegian study, published on July 2, 2019, reported on the hypophosphatemia incidence among inflammatory bowel disease (IBD) patients who took either Ferinject (Injectafer) or an alternative iron drug called Monofer. Their data comprised 106 patients from two separate hospitals in Norway. The researchers found that, after two weeks, over 56 percent of Ferinject patients developed moderate to severe hypophosphatemia compared to under 6 percent of Monofer patients.
After six weeks, over 13 percent of Ferinject patients and less than 2 percent of Monofer patients continued to experience symptoms. The researchers concluded that IBD patients taking Ferinject were more likely to experience severe HPP than those taking Monofer.
Now let’s look at some example Injectafer lawsuits that have been filed.
October 2020 Injectafer Lawsuit
On October 5, 2020, an Iowa woman filed an Injectafer lawsuit in the Eastern District of Pennsylvania. One year earlier, she underwent three monthly Injectafer injections. The woman subsequently developed severe hypophosphatemia. As a result, she suffered permanent injuries, including supraventricular tachycardia, bradycardia, bilateral foot stress fractures, bilateral ankle pain, and ambulating difficulties. The woman claimed Injectafer caused them. She alleged defective design, failure to warn, and negligent misrepresentation against American Regent, Luitpold Pharmaceuticals, Daiichi Sankyo, and Vifor Pharmaceuticals.
February 2021 Injectafer Lawsuit
Several months later, on February 9, 2021, a married couple filed suit in Pennsylvania federal court. Two years earlier, the wife underwent two Injectafer injections within one week. She then experienced severe hypophosphatemia symptoms, including muscle weakness and pain, joint and bone pain, and recurring fatigue. The couple alleged that American Regent, Daiichi Sankyo, Luitpold Pharmaceuticals, and Vifor Pharmaceuticals designed a defective drug, knew of the defects, failed to warn the public, and misrepresented its safety.
File Your Injectafer Lawsuit
If you were injured by Injectafer, our dangerous drug lawyers can help get the compensation you deserve. Call us today at 800-553-8082 to file your Injectafer lawsuit.