The Injectafer lawsuits claim the injection of this drug increases the risk of hypophosphatemia (HPP) and severe hypophosphatemia.
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What Do We Know About the Injectafer Lawsuits?
The Food and Drug Administration approved Injectafer (ferric carboxymaltose) on July 25, 2013, as an intravenous iron replacement product for treating iron deficiency anemia in adult patients who show intolerance to or have had an unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease. The drug is the only FDA-approved product that contains ferric carboxymaltose (FCM).
A 2016 study revealed that patients who received ferric FCM injections showed a 45% prevalence of hypophosphatemia (HPP) and a 32% prevalence of severe HPP. Another type of intravenous iron supplement, iron isomaltoside (IIM), showed only a 4% prevalence of HPP and no severe HPP.
Despite this and other studies casting light on the HPP-FCM connection, Injectafer manufacturers failed to adequately warn consumers about the risks of taking the drug. The prescribing information for Injectafer touches on such mild side effects as nausea, headaches, and “low levels of phosphorous in the blood,” without fully underscoring the dangerous and potentially deadly risk of HPP.
What are the Main Legal Issues Involving Injectafer?
The primary legal issue is whether the manufacturer of Injectafer failed to adequately warn doctors and patients about the increased risk of hypophosphatemia caused by Injectafer.
As of April 9, 2021, at least 59 individual Injectafer-related lawsuits have been filed by individuals in the United States District Court for the Eastern District of Pennsylvania.
Several companies are involved in the design, development, manufacture, and marketing of Injectafer. These companies include:
- American Regent, Inc.
- Daiichi Sankyo Group;
- Luitpold Pharmaceuticals, Inc.;
- Vifor Pharmaceuticals Management;
Injectafer Injuries & Side Effects
As of April 2021, the FDA has received a total of 4,700 adverse event reports related to Injectafer, Ferinject, and/or FCM. Of these reports, 3,263 were coded as serious. Death was reported as an outcome in 137 reports.
The reports reference a broad range of injuries and side effects from people who have taken the intravenous iron supplement, including the following:
- 332 cases of hypophosphatemia
- 62 cases of respiratory distress
- 47 cases of various types of bone fractures
- 43 cases of seizure
- 33 cases of osteomalacia
- 26 cases of cardiac failure
- 20 cases of cardiac arrest
- 19 cases of arrhythmia
- 17 cases of hypophosphataemic osteomalacia
- 14 cases of rhabdomyolysis
- 14 cases of respiratory arrest
- 11 cases of respiratory failure
- 11 cases of atrial fibrillation
- 5 cases of acute respiratory failure
From 2013 to 2019, the FDA saw a steady increase in the reporting of adverse events in which Injectafer, Ferinject, and/or FCM were identified as a likely cause. By 2020, the agency saw a dramatic spike in cases reporting hypophosphatemia and/or osteomalacia-related events in which Injectafer, Ferinject, and/or FCM were identified as a likely cause.
What Compensation is Recoverable in an Injectafer Lawsuit?
If you have received an Injectafer injection and suffer from hypophosphatemia (HPP), you might be entitled to the following types of compensation:
- Past and future medical expenses to treat your injuries.
- Past and future pain and suffering that results from your injuries, both from a physical and mental standpoint.
- Wage loss, if any.
- Other economic losses experienced because of your injuries.
- Punitive damages, if appropriate.
What is the Purpose of Injectafer?
Injectafer is used to treat patients with an adult iron deficiency anemia (IDA), a condition that causes fatigue, weak muscles, shortness of breath, pale skin, and lightheadedness. When the human body does not have enough iron in its blood, an individual experiences lower hemoglobin output. Because hemoglobin carries oxygen to organs and cells throughout the body, a low production causes patients’ cells and organs to cease normal function.
Typically, IDA is treated with oral iron supplements. In some cases, however, patients’ bodies do not absorb the orally ingested iron. Doctors may consider such individuals candidates for intravenous iron.
As an injectable form of FCM, Injectafer enters the body directly into the bloodstream. The medication then works by gradually releasing iron to relieve IDA symptoms. Usually, a patient will receive two intravenous doses at least seven days apart, with repeated treatments administered if necessary.
Researchers involved in a 2016 study concluded that FCM treatments are “associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.”
Patients who suffer from hypophosphatemia have a serum phosphate concentration less than 2.5mg/dL (0.81mmol/L). The symptoms of the condition largely depend on how much phosphate depletion the patient experiences, with symptomatic patients typically having plasma phosphate concentrations below 1mg/dL (0.32mmol/L).
Severe hypophosphatemia has been associated with several adverse outcomes, including:
- Bone fracture
- Bone pain
- Heart failure
- Heart rhythm disorders
- Muscle weakness
- Respiratory failure
The Timeline Important to the Injectafer Lawsuits
July 2013: The Food and Drug Administration approves Injectafer for the U.S. market.
December 1, 2016: PLOS ONE scientific journal publishes a study in which researchers concluded that “Treatment with FCM is associated with a high risk of developing severe and prolonged HPP.”
January 18, 2019: Katherine Crockett files a lawsuit over the side effects of Injectafer, claiming that the drug caused her to suffer low phosphorous levels that proved life-threatening
August 29, 2019: Celeste White files a lawsuit in the United States District Court Eastern District of Pennsylvania after taking Injectafer for her IDA and subsequently sustaining severe hypophosphatemia.
February 2020: The Journal of the American Medical Association publishes a study showing that the incidence of HPP was 75% in Injectafer patients, compared with only 8% in patients treated with Monofer, an iron isomaltoside.
October 2, 2020: Gregory and Margaret Yova file a lawsuit against Injectafer manufacturers after Gregory’s treatment resulted in critically low phosphate levels, generating severe and/or symptomatic HPP.
October 5, 2020: Savannah Brock files a lawsuit claiming that her Injectafer treatments caused her to suffer severe HPP, producing permanent injuries like bilateral leg pain, fatigue, shortness of breath, tachycardia, and other symptoms.
October 5, 2020: Mary Woodard files a lawsuit seeking damages after her Injectafer treatments caused her to suffer symptoms of severe and/or symptomatic HPP, generating supraventricular tachycardia, supraventricular ectopic beats, ventricular ectopic beats, bradycardia, bilateral stress fractures of the feet, and other injuries.
January 2021: Teresa J. Edwards files a complaint against Injectafer manufacturers after her treatments with the drug resulted in severe and/or symptomatic HPP, causing her to suffer such severe and permanent injuries as severe muscle fatigue and weakness, severe fatigue, and severe extended pain.
March 12, 2021: Nereida Sanchez and Jose Sanchez file a complaint claiming that two treatments of Injectafer caused her to suffer severe HPP symptoms, including blood phosphate levels as low as 1.0 mg/dL requiring phosphate supplementation, severe headache, severe muscle pain and weakness, bone and joint pain, and extreme fatigue.
Injectafer Lawsuit News
Injectafer Double Dose—Double Profit and Double Risk, and Dosage Discrepancy
Hypophosphatemia, an abnormally low level of phosphate in the blood, may be due to longer term use or excess of certain drugs such as bisphosphonates, including Injectafer, but that may depend upon researchers conducting the clinical trials and the amount of the iron-deficiency drug treatment. To read more, click LawyersAndSettlements.com.
New Clinical Trial Continues Trend of Studies Linking Injectafer to Severe Hypophosphatemia As Well As Associates the Drug with Bone Weakening
Once again, more clinical research is associating Injectafer (chemical compound: ferric carboxymaltose) with the dangerous and potentially life-threatening condition Severe Hypophosphatemia (Severe HPP). To read more, click Southeast Pennsylvania Injury Law News.
$2,733 To Treat Iron-Poor Blood? Iron Infusions For Anemia Under Scrutiny
A Kaiser Health News analysis of Medicare claims found that Injectafer and Feraheme — the two newest (and priciest) infusions on the American market — made up more than half of IV iron infusions in 2017, up from less than a third in 2014. Cheaper, older formulations — which can go for as little as a tenth the cost — have seen their share of Medicare claims fall dramatically. To read more, click NPR.org.
FDA Questioned Safety of Injectafer Long Before Approval
Several recent studies have indicated that Injectafer, more than other injectable forms of iron, can increase the risk of severe hypophosphatemia (HPP), a condition in which a patient is dangerously low on phosphate. Symptoms can include muscle wasting, seizures, respiratory failure, coma, and fatal arrhythmias. To read more, click New York Injury Law News.
FDA & Scientific Studies Regarding Injectafer
Dozens of published clinical trials, retrospective studies, case series, and case reports have reported a causal association between intravenous FCM treatments and hypophosphatemia. The following represents a small sampling of some of these studies.
Randomized trial of intravenous iron-induced hypophosphatemia
This study revealed a 50-percent higher incidence of HPP in individuals treated with Injectafer compared with patients who received an alternative iron therapy injection, ferumoxytol. To read more, click Journal of Clinical Investigation.
Choice of High-Dose Intravenous Iron Preparation Determines Hypophosphatemia Risk
PLOS ONE scientific journal publishes a study in which researchers concluded that “Treatment with FCM is associated with a high risk of developing severe and prolonged HPP.” Schaefer et al. conducted a retrospective, single-institution electronic medical record review to characterize the effects of different iron supplements on phosphate concentrations in 81 patients. Researchers found that ferric carboxymaltose administration was associated with a 20-fold greater risk of hypophosphatemia than iron isomaltoside 1000, and severe (0.3-0.59mmol/L) and life-threatening. To read more, click PLOS ONE.
Ferric carboxymaltose treatment for iron deficiency anemia in children with inflammatory bowel disease: Efficacy and risk of hypophosphatemia.
In a study of 128 children with inflammatory bowel disease treated with FCM, 19.5% children were found to have experienced low post-infusion serum phosphate, 1.6% of which developed severe hypophosphatemia. Authors concluded that serum phosphate monitoring should be mandatory due to the high prevalence of ferric carboxymaltose-induced hypophosphatemia. To read more, click Europe PMC.
Hypophosphatemia Is Common After Intravenous Ferric Carboxymaltose Infusion Among Patients With Symptomatic Heart Failure With Reduced Ejection Fraction
In a single-center retrospective study of the effect of intravenous FCM administration in 173 patients suffering heart failure with reduced ejection fraction, Dashwood et al. found that 47 (27%) patients experienced hypophosphatemia, 44 (25%) in which hypophosphatemia was classified as severe (0.4–<0.64mmol/L) and 3 (2%) in which hypophosphatemia was classified as extreme (<0.4mmol/L). Authors commented that biochemically relevant hypophosphatemia is common following a single dose of intravenous ferric carboxymaltose. To read more, click American College of Clinical Pharmacology.
Severe Symptomatic Hypophosphataemia as a Complication of Parenteral Iron Replacement
The European Journal of Case Reports in Internal Medicine reported on a 73-year-old male who developed severe symptomatic hypophosphatemia following 26 doses of ferric carboxymaltose for iron-deficient anemia over a three-year period. The condition resolved only upon cessation of intravenous ferric carboxymaltose and replacement with oral iron supplementation. To read more, click European Journal of Case Reports in Internal Medicine.
Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside-a systematic review and meta-analysis
The British Journal of Clinical Pharmacology reported on a systematic review and meta-analysis of 42 clinical trials of FCM and iron isomaltoside/ferric derisomaltose that found FCM induced a significantly higher incidence of HPP (47% vs. 4%) and significantly greater mean decreases in serum phosphate (0.40mmol/L vs. 0.06mmol/L) than iron isomaltoside/ferric derisomaltose. Schaefer et al. also noted that hypophosphatemia persisted at the end of the study periods in up to 45% of patients treated with FCM. To read more, click British Journal of Clinical Pharmacology.
A Pooled Analysis of Serum Phosphate Measurements and Potential Hypophosphataemia Events in 45 Interventional Trials with Ferric Carboxymaltose
In this Vifor-funded analysis, the scientists found that ferric carboxymaltose was associated with increased rates of serum phosphate lowering. Among 6,879 patients that received ferric carboxymaltose therapy, serum phosphate concentrations below 2.5mg/dL were recorded in 2,847 (41.4%), 49 (0.7%) in which serum phosphate concentrations were below 1mg/dL. Authors referred to hypophosphatemia as “a known adverse drug reaction with ferric carboxymaltose” and alleged that such information has been listed in the Injectafer product labeling since its original approval. To read more, click Journal of Clinical Medicine.