Is There An Iron Infusion Lawsuit Against Injectafer?
Yes, Injectafer lawsuit cases are currently being reviewed. Evidence shows that the iron infusions have been linked to a shockingly high rate of users developing dangerous drops in blood phosphate levels. This may result in a serious and potentially life-threatening condition known as symptomatic hypophosphatemia (HPP), causing users to experience:
- Severe Fatigue
- Muscle Weakness
- Joint or Bone Pain
- Mental Confusion
- Repeat Hospitalizations
- Other Complications
Since the drug makers failed to adequately warn about these potential Injectafer iron infusion side effects,many doctors and users did not recognize the symptoms or misdiagnosed the problems as a symptom of iron deficiency anemia (IDA), which Injectafer is intended to treat.
Left untreated, problems from Injectafer may persist for months or cause Severe HPP, potentially leading to other serious conditions, like Osteomalacia, Cardiac Arrhythmias, Cardiac Arrest, Respiratory Failure, Kidney Failure, Rhabdomyolysis, Seizures and Wrongful Death.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential Injectafer lawsuits and class action claims for individuals nationwide. There are no attorney fees or expenses unless an Injectafer iron infusion settlement or payout is obtained from the drug manufacturer.
Injectafer Lawsuit Info On This Page
Negative Experiences with Injectafer®
Allegations in Injectafer® Lawsuits
What is the Criteria for an Injectafer® Case?
Any costs to have an Injectafer® attorney review my case?
Factors considered in an Injectafer® settlement
Injectafer® Recall and Warning Information
Injectafer® Lawyer FAQs
History of Injectafer® and hypophosphatemia
Injectafer Lawsuit Update 2024
The Injectafer attorneys at Saiontz & Kirk, P.A. are still accepting new clients who suffered an injury after iron infusion treatments. Free, no-obligation case evaluations are available to anyone concerned, and no fees or expenses are owed unless a recovery is obtained.
- Hundreds of individual Injectafer lawsuits are filed in the U.S. District Court for the Eastern District of Pennsylvania and Philadelphia County Court of Common Pleas;
- Injectafer lawyers are investigating additional cases that are likely to be filed throughout 2023;
- First Injectafer trials are expected to begin in June 2023, October 2023 and November 2023;
- No global Injectafer settlements have been reached at this time, but our attorneys expect this will change as more jury trials approach.
FEBRUARY 2023 INJECTAFER LAWSUIT UPDATE: The first Injectafer trial is scheduled to begin on June 5, 2023, in the U.S. District Court for the Eastern District of Pennsylvania, involving a lawsuit filed by Katherine Crockett. This will be followed by two additional “bellwether” trials currently expected to go before federal juries on October 2, 2023 and November 29, 2023.
While the outcome of these early trials or the amounts of any lawsuit payouts awarded will not have any binding impact on other claims, the cases will be closely watched and will have an impact on the average Injectafer settlement amounts during negotiations to resolve all individual cases.
Patients Report Negative Experiences with Injectafer
Although the drug makers knew or should have known about the increased health risks, the initial Injectafer FDA label warnings described only mild side effects, such as nausea, headaches and low levels of phosphorous in the blood. Information was specifically withheld about the serious nature of low phosphorus symptoms, which lead to persistent or severe HPP from Injectafer..
A number of independent studies and case reports have found that the Injectafer iron infusion may cause phosphorous levels in the body to drop to dangerous levels
- In 2016, researchers found that 45.5% of patients treated with Injectafer were hypophosphatemic, with 32% developing severe HPP. By comparison, only 4% of users of the alternative iron isomaltoside experienced blood phosphate drops, with no cases of severe HPP associated with that other iron infusion treatment.
- Other studies have reported between 27% and 75% of Injectafer infusions result in HPP, with about one-third of individuals developing what is categorized as severe HPP.
The Injectafer warnings provided since the iron infusion was introduced in July 2013 contained false and misleading information for users and the medical community, which was intentionally designed to minimize the Injectafer risks and encourage wider sales of the intravenous iron infusion treatment.
Label information described decreases in serum phosphorus after Injectafer injections as “transient”, suggesting that the problems only last for a short time and pose minimal risks. The problems were also described as “asymptomatic”, leading the medical community to interpret that hypophosphatemia following Injectafer infusions did not rise to the level of severe HPP.
Data was available as early as 2006, which made it clear the Injectafer blood phosphate problems were not “transient” or “asymptomatic”.
The drug makers placed their desire for profits before the health and safety of patients by overstating the Injectafer benefits and minimizing the potential risks after an iron infusion.
Allegations in Injectafer Class Action Lawsuits
Individuals throughout the U.S. are now pursuing Injectafer lawsuits and class action claims, alleging that the drug makers:
- Failed to monitor and adequately test blood phosphate levels after Injectafer during clinical trials and studies before the iron infusion was introduced;
- Failed to investigate adverse event reports involving Injectafer problems cause sharp drops in phosphate levels;
- Failed to accurately disclose the rates of severe HPP from Injectafer that were experienced after iron infusions;
- Failed to warn about the long-term side effects of HPP, including rhabdomyolysis, cardiac arrest, heart arrhythmia, respiratory failure and death.
- Failed to warn about the differences between mild, moderate and severe HPP, and the risks associated with long-term persistent HPP that some users may experience;
- Failed to recommend monitoring serum phosphorous levels after Injectafer injections;
- Failed to recommend phosphorous supplements after iron infusions with Injectafer
You or a loved one may be eligible for an Injectafer settlement if an intravenous (IV) iron infusion was received during or since 2013, and any of the following were experienced:
- Hospitalized due drops in blood phosphorous levels, which may cause muscle fatigue, weakness, renal wasting or pain
- Respiratory Failure
- Acute Renal Failure
- Bone Fractures
- Cardiac Arrhythmias or dysrhythmias
- Cardiac Arrest
- Heart Failure
- Wrongful Death
Are there any costs to have an Injectafer attorney review my case?
There are absolutely no out-of-pocket costs to review your case or hire our Injectafer attorneys. Potential claims are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis. This means you pay nothing up front to hire our iron infusion lawyers, and we only receive an attorney fee or expenses if a payout is obtained. Our law firm receives nothing unless we win.
Request a free consultation and case review on line or call 1-800-522-0102 to get started. There are no attorney fees or expenses unless you win a settlement or recovery!
Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their Injectafer lawsuit settlement — regardless of their individual financial resources.
Steps in an Injectafer Hypophosphatemia Case Evaluation
Complete Our Case Evaluation Request Form. Providing contact information and some information about your Injectafer infusion case.
Get Contacted by Saiontz & Kirk, P.A. You will be contacted by our Injectaferlaw firm to help determine if financial compensation may be available for you and your family.
You Decide If You Want to Move Forward. If our lawyers determine that we can help with your Injectafer case then you decide whether to move forward and hire our us to pursue compensation.
Contact Saiontz & Kirk, P.A. For A
FREE CONSULTATION AND CASE EVALUATION
After speaking with our infusion injury law firm to review what options may be available, it remains your decision whether to form an attorney-client relationship and pursue a claim against Injectafer.
When will I find out if I have an eligible case against Injectafer?
After requesting a free case evaluation, our lawyers are often able to determine whether we can move forward with your Injectafer case following a short initial consultation. However, in some circumstances it is necessary that additional details be obtained before we can confirm that an Injectafer case is eligible.
If you decide to hire our law firm, you will be asked to sign a contingency fee agreement with our Injectafer attorneys, which confirms that there are no out-of-pocket costs associated with pursuing a case and that our lawyers are only paid if we are successful obtaining a recovery in your case.
As part of the Injectafer lawsuit evaluation, it will also be necessary for you to sign a medical authorization, so that we can obtain records confirming the injuries experienced after the iron infusion. Once it is confirmed that damages were caused by hypophosphatemia (HPP) or drops in blood phosphate levels after the iron infusion, our attorneys will confirm that you are eligible for an Injectafer settlement.
Throughout the process, you will have an opportunity to speak with our iron infusion attorneys to review any and all questions or concerns you may have.
What Types of Injuries Have Been Caused By Injectafer?
Due to the failure to warn about the link between Injectafer infusions and side effects, many cases of hypophosphatemia were misdiagnosed or not properly treated, increasing the severity of problems following the iron injection.
Researchers have found that more than 42% of severe HPP cases are not recognized or appropriately treated. The risk of a misdiagnosis with Injectafer is especially high, since the initial symptoms of low blood phosphate levels can be very similar to iron deficiency anemia (IDA) in many cases
Individuals with anemia already experience low energy levels, fatigue and other complications that may also be early warning signs of hypophosphatemia from Injectafer, such as:
- Generalized weakness
- Muscle, joint and bone pain
- Mental confusion
- Difficulty walking or moving around
- Bone fractures
As a result of the failure to warn about the risks after an Injectafer injection, many individuals were repeatedly hospitalized or visiting emergency rooms following iron infusions, and may have developed permanent injuries like:
- Osteomalacia (softening of the bones)
- Arrhythmias (cardiac arrhythmias or dysrhythmias)
- Heart failure
- Cardiac Arrest
- Respiratory Failure
- Acute renal failure
- Acute hemolytic anemia
Other Injectafer injuries reported among individuals experiencing HPP following the iron infusion include:
- Renal wasting
- Avascular necrosis of the hip bone
- Lumbar spine compression fractures
- Stress fractures
- Atrial Fibrillation
- Supraventricular tachycardia
- Supraventricular ectopic beats
- Ventricular ectopic beats
- Ankle pain
- Pedal edema
Who is the Injectafer Lawsuit Against?
Injectafer claims are being pursued against the drug companies responsible for the development and sale of the iron infusion treatment.
Lawsuits are not being pursued against individual doctors who prescribed or administered the IV iron injections, as medical providers were also provided false and misleading information.
Four pharmaceutical companies are named as defendants in Injectafer class action lawsuits and product liability claims filed for individuals throughout the United States. Each of these companies had responsibility for clinical trials, marketing, safety reporting and failing to warn users and the medical community about the risks associated with Injectafer:
- American Regent, Inc. is listed as the official manufacturer of Injectafer, and is a subsidiary of Luitpold Pharmaceuticals and the parent company Daiichi Sankyo.
- Luitpold Pharmaceuticals filed the New Drug Application for Injectafer, and was the parent company for American Regent for the first five years Injectafer was on the market. On 12/31/2018, Luitpold merged itself into its subsidiary, and renamed the resulting company American Regent.
- Daiichi Sankyo Group is a Japanese pharmaceutical company, which is the parent company of Luitpold and American Regnet, and generates annual revenue in excess of $8.8 billion.
- Vifor Pharmaceuticals was the original developer of the bioequivalent ferric carboxymaltose (FCM), which is the active ingredient in Injectafer. The iron infusion is sold under the brand name Ferinject in Europe, and Vifor licensed the design to Luitpold for the U.S. market.
Rather than investing in the safety of Injectafer, these companies placed their desire for increased revenues and drug sales before consumers’ safety.
As a result of the failure to warn, Injectafer lawsuits seek compensatory damages, as well as punitive damages designed to punish the gross negligence and reckless disregard for the health of individuals with iron deficiency anemia (IDA)
Factors Considered in Injectafer Settlement Negotiations
Ultimately, the amount of compensation and benefits each individual claimant will be entitled to receive will either be determined at trial, or negotiated based on the circumstances in the case and what a jury would likely award.
The Injectafer settlement negotiations will take into account the strength of the evidence linking the iron infusions to hypophosphatemia injuries, as well as the specific impact the Injectafer injury had on our client’s life.
In determining any Injectafer lawsuit settlement amount, the following are some of the common factors that a jury may consider, and which will be taken into consideration when evaluating any offers negotiated:
- The extent and duration of the injuries following the iron infusion;
- The effect of Injectafer-induced hypophosphatemia on the overall physical and mental health or well-being of the plaintiff;
- The pain and mental anguish suffered in the past and which will likely be suffered in the future;
- The amount of any past or future medical expenses incurred in treating the Injectafer injury;
- The amount of lost wages or lost earning capacity;
- The likelihood that a jury awarding punitive damages due to the drug maker’s reckless disregard for the health of consumers or gross negligence.
Following the investigation and litigation of a claim, each individual client will have the option to accept their Injectafer settlement or reject the offer and take their case to trial.
How much money will I get to settle my Injectafer claim?
Injectafer claims are expected to provide substantial compensation and settlement benefits, which will be based on the extent of the injury suffered by each plaintiff, including:
- Coverage for Medical Expenses and Treatments
- Compensation for Pain and Suffering
- Past and Future Lost Wages or Earning Capacity
- Other Benefits for Injuries Caused by Injectafer
While hundreds of lawsuits are likely to be pursued by individuals who have experienced similar injuries, the amount of compensation that will be paid to settle Injectafer lawsuits will depend on the individual circumstances in the case. To help determine the Injectafer settlement amount that you or a loved one may be eligible to obtain, request a no-obligation claim review.
How long will it take to receive my Injectafer settlement money?
At this time, the drug makers are not offering any Injectafer settlements and maintain that they intend to defend individual claims at trial. However, based on the strength of the case and evidence that the drug makers withheld important safety information, our lawyers feel confident that we will be successful negotiating to settle Injectafer claims in the future.
The first Injectafer lawsuits were filed in early 2019, and it is not expected that cases will start to go before juries until 2022 or 2023.
In complex pharmaceutical litigation, it is not uncommon for several early “bellwether” claims to go to trial before the drug maker agrees to enter settlement negotiations. While the outcomes of these early “test” trials will not be binding on other parties, they do provide a gauge for how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims.
If the drug makers fail to establish that they can consistently defend the safety of Injectafer in court, hundreds of individual Injectafer lawsuits may be set for trial in the coming years. However, based on the strength of the evidence in the litigation, our Injectafer lawyers believe the drug makers will eventually come to the table to discuss settling Injectafer cases.
It is impossible to know at this time how long it will take for an Injectafer settlement to be reached, but it is not uncommon in mass tort lawsuits for claims to start settling between 3 years and five years after the litigation emerges.
Find out if an Injectafer settlement payout may be available
Injectafer Recall and Warnings Information
Was there an Injectafer recall issued for the IV iron injection?
No, the FDA has not indicated that an Injectafer recall will be issued, and the intravenous iron injection remains on the market in the United States.
Unless health regulators determine that the Injectafer risks outweigh any potential benefits provided by the iron infusion compared to other treatment options, it is unlikely that the agency will require a recall for Injectafer. However, the drug maker has issued a number of Injectafer FDA label warning updates over the past few years.
Pharmaceutical companies have a duty to fully research their medications and disclose risk information to users and the medical community. It is critical that fair and accurate information about side effects be provided, to provide consumers with the information necessary to make a choice about whether to receive a medication.
Rather than removing Injectafer from the market, problems caused by hypophosphatemia may largely be avoided with accurate label warnings, which make sure all individuals are aware of the risk and monitor serum phosphate levels after the iron infusion.
What Injectafer risk information was provided on FDA label warnings?
Although Luitpold and American Regent knew about the link between Injectafer and hypophosphatemia before the drug was ever introduced in the United States, false and misleading information has been provided on various FDA label updates issued by the drug makers.
Over the past few years, the drug makers have been required to update the Injectafer label warnings several times, and lawsuits allege that information provided about the potential side effects following an iron infusion remains misleading and inadequate:
July 2013 Warning Label
When the injection was first introduced, potential side effects of Injectafer were minimized on the July 2013 Warning Label. Reports of problems involving reduced blood phosphorus levels were described as “asymptomatic”, and the label downplayed the serious risks associated with the medication by only mentioning symptoms like headaches, hypertension, dizziness and flushing that may result.
The initial “Warnings and Precautions” section of the label did not include any mention of hypophosphatemia or serious consequences that can result from drops on phosphate levels, including rhabdomyolysis, cardiac arrest, heart arrhythmia, respiratory failure and death.
The “Adverse Reactions” section described only “transient” decreases in laboratory blood phosphorus levels, suggesting that the problems are only short lasting.
In reality, multiple reports established that users were experiencing persistent HPP that lasted for months, as well as cases of severe HPP, often resulting in permanent injury.
January 2018 Warning Label
After reports of HPP problems began to mount, changes to the Injectafer warnings were provided in a January 2018 FDA Label Update. The drug makers removed descriptions of Injectafer side effects as infrequent and mild, and also removed indications that low levels of phosphorus were “asymptomatic.”
However, the new label warnings still provided no reference to the risk of severe HPP from Injectafer, or the clinical significance of low phosphorus on the body. No information was provided about symptoms that can accompany even mild or moderate HPP, which prevented users and the medical community from detecting the problems before they became severe.
The new warnings continued to describe decreases in laboratory blood phosphorus levels seen during clinical trials as “transient,” intentionally minimizing the risks.
February 2020 Warning Label
The drug makers finally added hypophosphatemia to the February 2020 Warning Update, but the label continues to provide incomplete information by omitting any mention of Severe HPP cases, Persistent HPP cases or the serious Injectafer complications that can result from these conditions.
Monitoring of serum phosphate levels was recommended in the new label, but only for patients who require repeat Injectafer injections. Lawsuits allege that this is inadequate, as it fails to indicate that ALL patients should have baseline testing and monitoring after treatment.
Information was added to the “Warnings and Precautions” section of the label about “symptomatic” hypophosphatemia for the first time, describing problems among individuals after repeated exposure to Injectafer. Hypophosphatemia was also described in the “Adverse Reactions” and “Postmarketing Experience” sections of the label. However, no information was provided about the conditions that may result from Injectafer HPP, such as rhabdomyolysis, kidney failure, cardiac arrest and bone fractures.
Are the Injectafer warnings still inadequate?
Even the Injectafer FDA label update in February 2020 fails to accurately warn about the risks users may face. As a result consumers and medical providers are still being deprived of information to make an informed choice about what treatment to obtain for iron deficiency anemia (IDA).
According to allegations raised in Injectafer class action lawsuits, the manufacturer should provide warnings that recommend:
- Monitoring for phosphate levels of ALL patients receiving a dose of Injectafer
- Obtaining baseline readings before and after infusions of Injectafer
- Provide phosphorus supplements after Injectafer injections
- Contraindicate Injectafer for those already at risk of low phosphate levels
If accurate information had been disclosed by the drug maker, many individuals may have avoided severe and permanent Injectafer injuries that may have been preventable.
Other Injectafer Lawyer Frequently Asked Questions (FAQ)
What is Injectafer?
Injectafer (ferric carboxymaltose or FCM) is an iron infusion treatment that is an injection received at a medical provider’s office, hospital, infusion center or during in-home care. It is typically administered intravenously (IV) in two 750 mg doses, which are separated by at least 7 days. However, in 2021, a new single 1000 mg dose was approved. In many cases, multiple courses of the iron infusion are prescribed.
The medication is indicated for treatment of Iron Deficiency Anemia (IDA) among adults who are unable to take oral iron supplements or those with chronic kidney disease (CKD) not receiving dialysis treatment.
Iron deficiency anemia (IDA) impacts more than 7.5 million people throughout the United States, occurring when there are insufficient levels of iron in the body.
Iron plays an essential role in the production of red blood cells, which carry oxygen to tissues and organs. While healthy individuals ingest iron from the food they eat, poor nutrition or an inability to absorb iron can lead to a deficiency. This results in a shortage of red blood cells, which makes it hard to maintain good health.
Women are at the highest risk of iron deficiency, with about 20% of black and Mexican-American women experiencing IDA, and 9 to 12% of non-Hispanic white women with the condition. However, it also impacts about 2% of men. Other groups facing an increased risk of iron deficiency include infants, children, vegetarians and those with conditions causing blood loss.
Is Injectafer Safe For Iron Deficiency?
Although it has been sold as a safe and effective iron deficiency treatment since July 2013, serious questions about the safety of Injectafer have emerged in recent years.
Several independent studies have found that side effects of the iron infusion may cause dangerous drops in blood phosphate levels, resulting in symptoms like:
- Generalized Weakness and Fatigue
- Muscle, Joint and Bone Pain
- Mental Confusion, Irritability or Anxiety
In many cases, the signs of serum phosphate decreases are very similar to the symptoms of anemia caused by iron deficiency, which can include pale skin, fatigue, shortness of breath, chest pain and headaches.
Injectafer is not safe if these signs are not promptly recognized as a different medical treatment, which can be treated with phosphorus supplements. However, due to a lack of warnings provided to users and the medical community, drops in blood phosphate levels following iron infusion treatments with Injectafer have often been misdiagnosed or not properly treated, resulting in repeated hospitalizations and severe health complications
According to allegations raised in a growing number of Injectafer lawsuits, drug makers knew about the risks associated with the iron infusion treatment, yet withheld information about the importance of monitoring for symptoms and blood phosphate testing during treatment.
Why are IV Infusion Treatments Given for Iron Deficiency Anemia (IDA)?
Individuals with iron deficiency anemia are traditionally treated with oral iron supplements. However, some people are unable to take the iron pills, or fail to respond to the treatment.
Intravenous (IV) iron injections were developed as an alternative treatment, involving direct iron infusion through a needle into the vein. This allows for a rapid and high-dose iron replenishment that is then slowly released into the bloodstream. The infusion typically takes place at a doctor’s office or medical clinic, often resulting in several visits.
While early forms of IV iron infusions caused severe complications and were only recommended in extreme conditions, over the past few decades pharmaceutical companies have introduced a number of modern intravenous iron supplements, including:
- Injectafer (ferric carboxymaltose), which is sold as Ferinject outside the U.S.
- Monofer (iron isomaltoside)
- Faraheme (ferumoxytol)
- InFed (low molecular weight iron dextran)
- Dexferrum (high molecular weight iron dextran)
- Ferrlecit (sodium ferric luconate complex)
- Venofer (iron sucrose)
Since many individuals receiving an injectable iron supplement may not be aware whether they received Injectafer or another IV infusion treatment, it is not necessary to know the specific product received before requesting a free case evaluation. Our Injectafer iron infusion lawyers can help determine whether you or a loved one may be eligible for a claim.
What is Hypophosphatemia (HPP) after iron infusions?
Hypophosphatemia (HPP) is the medical term used to describe the rare, but potentially serious condition that results from low levels of phosphorus in the body.
Phosphorous or serum phosphate is important to maintain a healthy body. It is vital for bone growth, energy storage, nerve production and muscle growth.
Medical providers may diagnose HPP after blood tests reveal abnormally low levels of phosphate in the blood. However, in many cases, individuals suffer side effects of HPP without ever receiving a formal diagnosis or hearing about this medical condition.
Other than cases resulting from Injectafer injections other common causes of HPP include:
- Diabetic Ketoacidosis
- Kidney Tubule Defects
- Genetic Phosphate Regulation Disorders
- Severe Malnutrition or Nutrient Deficiency
Failure to treat low phosphate levels caused by iron infusions like Injectafer can result in repeated hospitalizations from persistent HPP or severe HPP, increasing the risk of serious and potentially life-threatening complications like
What are the types of Hypophosphatemia (HPP) from Injectafer?
While the normal range of serum phosphate is between 4.5 and 2.5 mg/dl, if Injectafer causes phosphorous levels to drop below 2.5 mg/dl, this may be diagnosed as hypophosphatemia (HPP). Side effects of the condition can range from mild to severe:
Mild Hypophosphatemia: (2.5 to 2.0 mg/dl serum phosphate): may result in mild to moderate weakness, or occur without any noticeable symptoms at all. However, even repeated or persistent mild HPP can result in serious health consequences.
Moderate Hypophosphatemia: (2.0 to 1.0 mg/dl serum phosphate): may cause muscle weakness, fatigue, bone pain, appetite loss, irritability, numbness, confusion and other symptoms that may not be readily identified unless an individual knows to be monitoring for the signs from Injectafer.
Persistent Hypophosphatemia: chronic drops in phosphate levels that are typically categorized as mild or moderate, but persist over a period of time may be described as persistent HPP. The dangers of HPP from Injectafer not only come from extremely low phosphorous levels, but also the duration and severe complications may result.
Severe Hypophosphatemia: (less than 1.0 mg/dl serum phosphate) extremely low levels of phosphate can cause a medical emergency, or result in complications like bone fractures, osteomalacia, cardiac arrhythmias or dysrhythmias, heart failure, cardiac arrest, respiratory failure, rhabdomyolysis, renal failure, seizures, coma or death.
What Causes the Injectafer Risk of Hypophosphatemia (HPP)?
Injectafer has an effect on the FGF23 hormone (fibroblast growth factor 23), which is known to cause decreases in blood phosphorus levels.
The drug makers were aware that Injectafer increases levels of FGF23 at rates far greater than iron drugs before the infusion was introduced. They also knew or should have known that this would cause Injectafer users to experience severe hypophosphatemia (HPP), and additional injuries known to stem from that diagnosis.
It has been known since FGF23 was discovered in 2000 that it causes iron deficiency HPP through a reduction of phosphate reabsorption in the body. If the body has too much FGF23, the kidneys stop reabsorbing phosphorous.
In July 2013, the same year Injectafer was introduced, a study published in the medical journal BMC Nephrology concluded that the active ingredient ferric carboxymaltose (FMC) “causes a significant decrease in FGF23 levels”, which is known to result in a risk of HPP.
This was supported five years later in December 2018, when a study published in the Journal of Clinical Investigations (JCI) Insights noted that “ferric carboxymaltose (Injectafer) rapidly increases biologically active FGF23 in patients with iron deficiency anemia.”
History of Injectafer and Hypophosphatemia Studies
A study published in BMC Nephrology found that among 47 patients with chronic kidney disease, who were not on dialysis, a single 1000mg dose of ferric carboxymaltose (FMC) in Injectafer caused reductions in serum phosphate levels that persisted for three months. Researchers also found that exposure caused significant decreases in FGF23 levels, which is known to pose a risk of HPP.
Problems from Injectafer experienced by a 45 year old woman were described in Case Reports in Endocrinology, after she complained of intense fatigue about 10 days after the second dose. Blood analysis showed a dangerous drop in phosphate plasma levels. Researchers warned that “long-term monitoring of phosphate level is mandatory during [Injectafer] treatment and physicians must be aware of this potential side effect.”
A report published in the International Journal of Rheumatology concluded that the Injectafer “FCM injection is often followed by hypophosphatemia, which may be profound and last a long time without immediate clinical consequences except fatigue in some cases.” Out of 78 patients treated with injectafer, 51% developed HPP and 13% suffered severe HPP.
Study published in the medical journal PLoS One identified Injectafer as the “single most important risk factor” for the development of HPP. Researchers warned that there was a 20-fold higher HPP risk with Injectafer, when compared to the alternative intravenous iron infusion Monofer (iron isomaltoside).
According to the findings, 45.5% of Injectafer users had hypophosphatemia, with 32.7% of cases categorized as severe HPP. The alternative iron infusion Monofer had only 4% rate of HPP, with no cases progressing to severe HPP.
Similar findings were published in the British Journal of Clinical Pharmacology, compared Injectafer and Monofer. The study found HPP occurred in up to 50% of patients who received Injectafer compared to less than 10% with Monofer, and cases of severe HPP only occurred with Injectafer.
Findings published by the American Society for Clinical Investigation in the medical journal JCI Insights identified a six-times higher rate of HPP from Injectafer, compared to users of another iron therapy injection Faraheme (ferumoxytol). Researchers indicated that 58.8% of Injectafer users had severe HPP (levels under 2.0 in this study) and 10% of users had extreme HPP (levels under 1.3). In addition, 29.1% of Injectafer users had persistence of severe HPP at the end of the five-week study.
Medical journal Ailmentary Pharmacology and Therapeutics published a study that found FCM in Injectafer was associated with higher incidence, severity and persistence of HPP compared to iron isomaltoside. Moderate-to-severe HPP seen beyond six weeks after an iron infusion with Injectafer was noted as a clinical concern.
A comparison of Injectafer vs. Monofer published in the Journal of the American Medical Association (JAMA) evaluated data from two clinical trials. The incidence of HPP with Injectafer was 75% vs. 7.9% with Monofer in Trial A, and 73.7% with Injectafer vs Monofer’s 8.1% rate in Trial B. Researchers concluded that “even a single course of [Injectafer] may adversely affect the skeleton and may help explain why repeated dosing of [Injectafer] has been associated with osteomalacia and fractures.”
A systematic literature review published in the journal Therapeutics and Clinical Risk Management found the highest rates of HPP among patients with Injectafer treatment, compared to other iron products. Researchers warned that multiple cases have documented serious consequences of hypophosphatemia with certain IV iron treatments, and recommended pre and post-monitoring of serum phosphate levels.
In the European Journal of Case Reports in Internal Medicine, doctors described a patient with recurrent hospital admissions due to non-specific symptoms, which were attributed to iron deficiency anemia after multiple doses of Injectafer. However, he was actually found to have severe HPP, with renal phosphate wasting and elevated levels of FGF23. After stopping Injectafer, no further HPP problems were experienced.
A study published in the Journal of Clinical Pharmacology found that 27% of patients with heart failure administered Injectafer experienced HPP, with 25% classified as “Severe HPP” and 2% considered “Extreme HPP”. Researchers noted that the median time to “nadir” was 8 days.
A meta-analysis of 42 clinical trials published in the British Journal of Clinical Pharmacology found that Injectafer caused “significantly higher incidence of hypophosphatemia” and that the problems submitted at end of study periods in 45% of patients treated with Injectafer.
The medical journal Europe PMC published a study evaluating the use of Injectafer among children with inflammatory bowel disease, but warned that “due to the high prevalence of post-infusion hypophosphatemia, serum phosphate monitoring should be mandatory”.