Injectafer FDA Label Warnings About Hypophosphatemia (HPP) Risks Remain Inadequate

Austin Kirk

By Austin Kirk
Posted June 29, 2021


The Injectafer FDA label was updated in February 2020 with new information about severe hypophosphatemia (HPP) risks. However, these warnings remain insufficient and continue to provide misleading information, which fails to fully describe the serious and potentially life-threatening nature of Injectafer side effects that may be experienced after the iron replacement therapy.

The History of Inadequate Injectafer FDA Label Warnings

Injectafer (brand name for ferric carboxymaltose) was first introduced in the United States in July 2013, containing an initial FDA warning label (PDF) that downplayed the iron replacement therapy risks. Reports of serum phosphate drops were described as “asymptomatic” or “transient”, suggesting that they posed little concern. However, it has been clearly established that the drug makers knew this information was false, well before the Injectafer approval in the United States.

An updated ferric carboxymaltose FDA label (PDF) was issued in January 2018, which removed prior language that suggested the hypophosphatemia side effects were infrequent or mild. New warnings were also added to a Patient Information Sheet, acknowledging that “low levels of phosphorous in your blood” was among the most common side effects of Injectafer. However, no information was provided about potential symptoms of Injectafer causing hypophosphatemia, and the importance of monitoring serum phosphate levels after the iron replacement therapy.

In February 2020, the latest Injectafer label (PDF) was approved by the FDA, which provided added information about the hypophosphatemia risk to the “Warnings and Precautions” section for the first time, indicating:

5.4 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.

Injectafer and Hypophosphatemia: What does this Ferric Carboxymaltose FDA warning even mean for users?

While this latest Injectafer FDA label update is certainly an improvement over the initial warnings provided by the drug makers during the first seven years the iron replacement was on the market, it’s not enough.

Users and the medical community are still being provided false and misleading information about the severity of drops in phosphorus levels after an Injectafer infusion. In addition, patients are also still not provided any information about the symptoms that may accompany even mild or moderate hypophosphatemia, and the serious injuries that can result from persistent or severe HPP.

According to allegations raised in the mounting Injectafer hypophosphatemia lawsuits, many devastating health problems may have been avoided if clear warnings had been provided about the importance of seeking immediate medical treatment if users experience symptoms of serum phosphate deficiency, which may include:

  • Muscle Weakness
  • Joint and Bone Pain
  • Fatigue
  • Mental Confusion
  • Irritability or Anxiety
  • Nausea
  • Difficulty Walking

The Injectafer label suggests that monitoring blood phosphorus levels is only necessary after repeated courses of the iron replacement therapy. However, a growing number of experts actually recommend phosphorus testing before and after ALL Injectafer treatments.

Details about the severe consequences of Injectafer causing hypophosphatemia should also be provided for patients receiving the iron replacement treatment, including specific mention of the severe and life-threatening health conditions that have occurred among some users:

  • Osteomalacia, Osteoporosis and Bone Fractures
  • Rhabdomyolysis
  • Cardiac Arrhythmia, Tachycardia, Bradycardia or Atrial Fibrillation
  • Cardiac Arrest
  • Neuropathy
  • Respiratory Failure
  • Renal Failure, Acute Kidney Injury and Chronic Kidney Disease
  • Wrongful Death

How often do Injectafer users develop symptomatic hypophosphatemia?

While the passing reference on the Injectafer label makes it sound like hypophosphatemia is a rare occurrence, in reality this side effect occurs with shockingly high frequency.

Nearly half of all users may experience some level of hypophosphatemia from Injectafer, with about one-in-three cases resulting in severe HPP

In December 2016, a study published in the medical journal PLoS One found that 45.5% of individuals who received Injectafer as an iron replacement therapy had hypophosphatemia, with 32.7% of the cases categorized as Severe HPP, indicating that the problems were symptomatic and may constitute a medical emergency.

In December 2018, another study published in the medical JCI Insights found that 58.8% of Injectafer users had severe HPP (defined as serum phosphate under 2.0 mg/dl in this study) and 10% of users had extreme HPP (defined as levels under 1.3 mg/dl). In addition, 29.1% of individuals had persistent or severe HPP from the Injectafer therapy at the end of the five week study.

These findings and case reports describing symptomatic hypophosphatemia following Injectafer treatments by 2020, yet the drug makers decided to place the desire for profits before consumer safety by providing false and misleading information on the Injectafer FDA label.

Injectafer Hypophosphatemia Lawsuits For Failure to Warn

The lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who are pursuing an Injectafer lawsuit after suffering severe and often life-threatening health complications from the iron replacement therapy.

Serious injuries that result from side effects of hypophosphatemia (HPP) caused by Injectafer may not be recognized immediately after the low iron treatment. However, if you or a loved one experienced complications after an iron replacement infusion, financial compensation may be available due to the drug makers failure to adequately warn about the link between Injectafer and hypophosphatemia on the label.

All cases are investigated by our Injectafer lawyers on a contingency fee basis, which means that there are never any out-of-pocket costs to hire our law firm. We only receive fees or reimbursement of expenses out of any hypophosphatemia settlement or recovery obtained.


3 Comments • Add Your Comments

  • Sarah says:

    I had severe reaction to injectafer where I had shock had low blood pressure and sweating clammy skin and dizziness

    Posted on July 24, 2021 at 5:43 pm

  • Solange says:

    I have been taking injectafer for the past one year, never have I had or experienced the above mentioned side effects

    Posted on September 8, 2021 at 11:12 am

  • Roger says:

    As a patient of severe hypophosphatemia and a physician myself, I totally do not comprehend why this Iron infusion is still on the market while much safer alternatives are there.

    This side effect occurs so often with severe / longlasting or even chronic complaints, that the total impact of an infusion so often prescribed, is huge.
    Furthermore, because off the active hiding by the company (you can conclude this with certainty), it is also difficult to diagnose hypophosphatemia and relate it to the Iron infusion. This makes it even worse and more dangerous.

    After 8 months, 2 hospitalisations urgently needing phophate infusions for weeks, I’m still not able to work and I’m unfortunately not alone.

    Posted on December 1, 2023 at 4:06 pm

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