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.

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.

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.

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.

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

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)
• Others

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
• Hyperparathyroidism
• Genetic Phosphate Regulation Disorders
• Anorexia
• Alcoholism
• 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

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.

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.”