Injectafer Hypophosphatemia Lawsuits

The iron deficiency anemia injection Injectafer has been linked to hypophosphatemia (HPP), a condition characterized by dangerously low phosphorus levels in the blood which can often result in hospitalization.

Severe HPP occurs when serum phosphorus levels drop below 1 mg/dl and the condition can lead to serious and sometimes fatal medical complications, including seizures, respiratory failure, heart failure and coma. If you or a loved one has been hospitalized following the use of Injectafer, please contact us today to discuss your potential claim. We can help determine if you are eligible to file a claim for significant compensation against the manufacturer of Injectafer or participate in potential upcoming settlements.

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Injectafer Lawsuit Information

Despite medical evidence linking Injectafer to a higher rate of severe hypophosphatemia, no real warning about this potential risk existed on the drug label or in the prescribing information until February 2020, when the FDA finally announced a label change. Unfortunately, while the recent Injectafer label update does include a warning about “symptomatic hypophosphatemia,” the new warning fails to address the severity of the hypophosphatemia that Injectafer treatment can cause or the fact that severe HPP may occur at a much higher rate with Injectafer than with its competitors. This alleged failure to warn about symptomatic hypophosphatemia forms the legal basis for Injectafer users to file drug injury lawsuits against the pharmaceutical company responsible for Injectafer in the United States, American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals Inc. Drug injury attorneys across the country are currently hard at work investigating possible Injectafer claims on behalf of patients who developed hypophosphatemia and were diagnosed with one or more serious medical complications after receiving an Injectafer injection.

Potential Complications of Severe Hypophosphatemia

• Muscle weakness

• Rhabdomyolysis (breakdown of damaged muscle)

• Respiratory failure

• Cardiac arrest

• Osteomalacia (softening of the bones)

• Seizures

• Coma

• Death

What is Injectafer?

Injectafer (ferric carboxymaltose injection) is an intravenous iron replacement product used to treat iron deficiency anemia in adults for whom treatment with oral iron is unsuitable or unsuccessful. Iron deficiency anemia is a common condition that occurs when the body doesn’t have enough red blood cells from too little of the mineral iron, which is needed to help the blood carry oxygen throughout the body. The injection is designed to be administered directly into the vein, typically in two doses approximately seven days apart. Once inside the body, Injectafer gradually releases iron into the bloodstream, thereby providing the body with the iron it needs to function properly. However, there is evidence that Injectafer treatment may drastically reduce the amount of phosphorus in the body, which can lead to severe hypophosphatemia and other potentially life-threatening complications. In fact, when Injectafer was approved by the FDA in 2013, it was after previously being rejected due to a potential link between the treatment and “excess mortality and severe hypophosphatemia.”

Should You File an Injectafer Lawsuit?

Injectafer lawsuits include allegations that American Regent and Luitpold Pharmaceuticals:

• Failed to warn users about the potential risk of hypophosphatemia associated with Injectafer treatment.

• Ignored and hid studies linking Injectafer to severe hypophosphatemia side effects.

• Knew or reasonably suspected that using Injectafer could cause dangerously low phosphorus levels in the body.

• Marketed Injectafer as a safe and effective iron replacement treatment despite being aware of and covering up these potential risks.

Injectafer Linked to Hypophosphatemia

Medical research suggests that some patients receiving an iron injection treatment may develop hypophosphatemia, but a growing body of evidence shows that severe hypophosphatemia occurs more frequently in patients who receive Injectafer compared to other iron injection treatments. In one study published in 2018, researchers compared Injectafer to Feraheme, another IV injection indicated for the treatment of iron deficiency anemia. According to their findings, more than half of the patients treated with Injectafer developed severe hypophosphatemia and 10% developed extreme hypophosphatemia. Comparatively, less than 1% of those treated with Feraheme (ferumoxytol) developed severe hypophosphatemia and none developed extreme hypophosphatemia.

Another study published in the Journal of the American Medical Association in February 2020 found that 75% of patients who received Injectafer developed hypophosphatemia, compared to only 7.9% of patients given another iron infusion drug called Monoferric (ferric derisomaltose). Severe hypophosphatemia was reported in 11.3% of patients treated with Infectafer and in zero patients treated with Monoferric. The same month the JAMA study was released, the Injectafer label was updated to include the potential risk of symptomatic hypophosphatemia tied to Injectafer treatment. The Injectafer label warning now reads:

Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.

Injectafer Lawsuit Resources

Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia Two Randomized Clinical Trials

Injectafer Label

5.2 Symptomatic Hypophosphatemia

Symptomatic hypophosphatemia requiring clinical intervention has been reported in
patients at risk of low serum phosphate in the postmarketing setting. These cases have
occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment. [see Dosage and Administration (2.3)].

Phosphorus and Your Diet

WebMD – Injectafer

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