Injectafer Lawsuits Allege Drug Causes Severe Hypophosphatemia

Injectafter lawsuits have been filed around the country amid allegations that the iron supplement causes hypophosphatemia (HPP), leading to fatigue, muscle pain and weakness, and bone pain.

Infectafer Lawsuit Update – July 2022

A total of 13 Injectafer product liability lawsuits have been filed in federal courts so far in 2022. 12 of the 13 Injectafer lawsuits were filed in the Eastern District of Pennsylvania and 1 of the cases was filed in the Middle District of Florida.

There are now a total of about 40 Injectafer lawsuits pending in federal courts and a similar number of cases pending in Pennsylvania state courts. There is still no indication that an MDL consolidation may be in the works and unless the number of cases increases dramatically that is unlikely to change.

Injectafer History

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.

Injectafer is the only intravenous iron product in the U.S. formulated with the unique ferric carboxymaltose (“FCM”) compound. FCM can cause severe hypophosphatemia (“HPP”).

Hypophosphatemia is an abnormally low level of phosphate in a person’s blood. There is no warning on Injectafer for HPP.  It is included as an “adverse reaction” qualified by the contention that it occurs in less than two percent of patients.  But severe HPP can cause respiratory failure, arrhythmias, cardiac arrest and rhabdomyolysis.

Shortly after FDA approval, studies revealed that the use of Inectafer could cause severe hypophosphatemia (HPP) in some patients.

Injectafer Lawsuits

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 firm is currently accepting new Injectafer lawsuits.

How Injectafer Works 

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 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 it.

What Is Hypophosphatemia?

Hypophosphatemia (“HPP) is low levels of phosphate in your blood.  Phosphate advances your energy and nerve function and regeneration.  It is also important for maintaining strong bones.  is an electrolyte that helps your body with energy production and nerve function. Phospate also helps build strong bones and teeth. You get phosphate from foods like milk, eggs, and meat.

Injectafer/Hypophosphatemia Side Effects

Common Injectafer side effects created by hypophosphatemia include:

• Severe allergic reactions include itching, rashes, hives, wheezing, shock, low blood pressure, lost consciousness, and death.
• High blood pressure
• Facial flushing
• Headaches
• Dizziness
• Nausea
• Breathing difficulties
• Fever
• 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, drum roll please, 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. #redflags

Studies Linking Injectafer to Hypophosphatemia

There are studies that support the contention that Injectafter leads to phosphate deficiencies:

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, 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 in July 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.

• 2020 study raising concerns about hypophosphatemia 

Ongoing research continues to explore the link between ferric carboxymaltose and HPP, with recent studies supporting claims of its potential to cause significant health issues. These studies are critical in supporting the litigation and providing scientific backing for the plaintiffs’ claims.

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.

The attorneys’ Injectafer lawsuit alleged 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.

Sample 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.

In February 2020, Injectafer’s FDA label was updated and it mentions the hypophosphatemia risk. But this is not a real warning that fairly presents the potential grave risks to patients and the need for carefully monitoring blood phosphate levels after an iron injection.

Are Venofer Lawsuits on the Horizion?

There are other iron injections available on the market. Besides Venofer, there is Feraheme, Infed, Dexferrum, and Ferrlecit. Will there be lawsuits involving Venofer or these products? Do they cause hypophosphatemia? Right now, Injectafer is the target but it remains to be seen what will happen with other iron injections.

Is Your Law Firm Handling Injectafer Lawsuits?

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