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Injectafer Lawsuit


Injectafer (ferric carboxymaltose) is an intravenous iron replacement medication prescribed to adult patients for the treatment of iron deficiency anemia. Research indicates that patients taking the iron replacement product are at high risk of developing hypophosphatemia (HPP), a condition that can be life-threatening. Injectafer lawsuits allege that consumers and the medical community were not adequately warned of Injectafer HPP risk and other adverse side effects.

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Injectafer Research and Clinical Studies

Manufactured by Daiichi Sankyo, Injectafer (active ingredient ferric carboxymaltose) is prescribed to treat iron deficiency anemia (IDA) in adult patients who cannot tolerate oral iron supplements. With 4.5 million Americans suffering from IDA, intravenous iron medication has recently escalated in popularity. The traditional treatment has been oral iron supplements, but the pharmaceutical industry has pushed the IV alternatives as they pack a stronger punch. As well, patients see results more quickly and take the drug less frequently.

But the benefits of IV drugs can be outweighed by serious complications. Numerous studies and research suggest that side effects of Injectafer could cause severely low phosphorus levels known as hypophosphatemia (HPP).

Testosterone injecion thumb 2In August 2019, researchers from Norway reported in the journal Alimentary Pharmacology & Therapeutic that side effects of Injectafer were linked to a higher rate of HPP than other IV low iron treatments, known as iron isomaltoside or Monofer. (Hypophosphatemia is a side effect of both preparations.)  According to the findings, 130 patients with inflammatory bowel disease given Injectafer showed a significantly higher risk of moderate-to-severe HPP by week two of treatment. (Iron deficiency and anemia are common complications linked to IBD.)

The study concluded at week 6: “The presence of moderate‐to‐severe hypophosphatemia beyond 6 weeks is a clinical concern that requires further investigation,” said researchers.

Researchers in Austria in 2016 found that Injectafer increases the risk of HPP compared to 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. In a follow-up letter to the editor one year later, doctors indicated that HPP had occured in up to 70 percent of patients treated with FCM.

A study in 2000 detailed HPP, saying that “ Chronic hypophosphatemia…results in hematologic, neuromuscular, and cardiovascular dysfunction, and unless corrected, the consequences can be grave… Researchers also noted delays in diagnosing HPP:
 
“It is hard to provide precise estimates of how many patients are seen with hypophosphatemia annually at academic medical centers. This is complicated by use of chemistry panels that do not measure inorganic phosphate unless specifically ordered. This often leads to delay in correct diagnosis, and, therefore, additional delay in providing appropriate management. A high index of suspicion alone avoids the unnecessary withholding of treatment that can be life saving.”

In 2013, the same year Injectafer was approved by the FDS, a study published in BMC Nephrology found "significant decreases" in Serum Phosphorus levels of non-dialysis chronic kidney disease patients three weeks after receiving a single dose of Injectafer to treat iron deficiency anemia.  The levels remained low for 12 weeks after the infusion.

Most recently, in a clinical trial involving 2,000 anemia patients, more than half of those given Injectafer developed severe hypophosphatemia. But the rate of hypophosphatemia among Feraheme (ferumoxytol injection) patients was less than 1 percent.

Injectafer and the FDA

The FDA initially declined to approve Injectafer in 2008, after premarket clinical trials identified “excess mortality and severe hypophosphatemia” as possible safety risks. When the FDA approved Injectafer in 2013, there was one reported case of hypophosphatemic osteomalacia-- a metabolic disease characterized by low concentrations of serum phosphate levels, according to Experimental and Therapeutic Medicine.

Listed on the patient information sheet, (revised in January 2018), the most common side effects included:
  • nausea
  • high blood pressure
  • flushing
  • dizziness
  • low levels of phosphorous in your blood

Missing from Injectafer’s label was a warning of severe HPP and the severe health complications that can result from extremely low levels of phosphorous (an essential mineral that provides structure and strength to the human body and is used for growth and repair of the body’s cells and tissues).  HPP health complications include:
  • Cardiac arrest
  • Respiratory failure
  • Seizures
  • Muscle weakness
  • Coma
  • Death
 
In February 2020 the FDA ordered “symptomatic hypophosphatemia” added to the list of potential side effects on the label for Injectafer. The agency’s warnings came after multiple clinical trials confirmed that Injectafer posed an increased risk of HPP.

Injectafer Lawsuits

Lawsuits filed against the manufacturer, American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc., allege failure to warn about the serious risk posed by Injectafer, leaving patients and doctors unaware of the danger. Defendants also include Luitpold Pharmaceuticals, Inc., Daiichi Sankyo, and Vifor Pharmaceuticals Management Ltd.

A North Carolina woman in September 2019 filed a product liability lawsuit claiming that Injectafer side effects resulted in severely low and damaging phosphorous levels; that manufacturers knew, or should have known of the risks of HPP from Injectafer but failed to provide adequate warning to the medical community or patients; and that with the failure to warn of HPP, the label also fails to warn of the potential injuries which could result.
Celeste White filed her complaint in the U.S. District Court for the Eastern District of Pennsylvania. White claims she was prescribed Injectafer in 2014 to treat Iron Deficiency Anemia (IDA). She took the injections six times, and developed severe HPP.  One month before the lawsuit, the Norwegian researchers published their study (above).

Another complaint filed in January 2020 also claims that consumers and the medical community have not been adequately warned about the potential side effects of Injectafer.  Maria Munroe and her husband, Anthony filed the lawsuit in the U.S. District Court for the Eastern District of Pennsylvania, claiming that Injectafer is unreasonably dangerous and defective. Monroe states that she was prescribed IV Injectafer in September 2018. After receiving two treatments, severely low levels of phosphorous resulted in hospitalization and the need for IV phosphate infusions. About one month later she was also diagnosed with increased phosphate renal excretion and her phosphate levels failed to stabilize. Munroe is diagnosed with HPP, which she blames on the side effects of Injectafer. As a result of HPP, she has been hospitalized three times and must continue to take daily phosphate supplements.

And another lawsuit was filed April 2020 by Christa C., an Idaho woman with iron-deficiency anemia. She was treated with Injectafer in 2016 and soon developed HPP, which was so severe she was unable to work for 10 works due to chest pain, heart palpitations, shortness of breath, insomnia, bone and joint pain, and a general deterioration of her health, according to the lawsuit filed in the U.S. District Court for the Eastern District of Pennsylvania — Case No. 2:20-cv-02019.

Anemia patients who suffered severe HPP after Injectafer treatments may be entitled to financial compensation for all of their injury-related damages. More Injectafer lawsuits have been filed since the FDA ordered the drug makers to add “symptomatic hypophosphatemia” to the list of potential side effects on the Injectafer label.
 

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INJECTAFER LEGAL ARTICLES AND INTERVIEWS

“Now is not the time to tinker with Injectafer labeling,” says Attorney
“Now is not the time to tinker with Injectafer labeling,” says Attorney
September 2, 2020
West Palm Beach, FL Injectafer, an intravenous iron replacement drug, has recently caught the attention of researchers and the medical community, and in their wake, the legal community. Increasingly, researchers found that the benefits of Injectafer can be outweighed by the serious side effect of severely low phosphorus levels known as hypophosphatemia (HPP). Attorney Brenda Fulmer explains why this drug is still on the market and why patients are filing Injectafer lawsuits.
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