Injectafer Lawsuit

Injectafer Lawsuit

Injectafer lawsuits claim the iron replacement drug, also known as ferric carboxymaltose, causes hypophosphatemia (HPP) or low phosphate levels.

Severe hypophosphatemia (HPP) can cause serious health problems, including bone pain, seizures, and death.

Injectafer lawyers say the drug makers failed to warn the public of the risk.

Did you develop hypophosphatemia or other serious side effects after receiving Injectafer?

Table of Page Contents

Why Are People Filing an Injectafer Lawsuit?

People who filed Injectafer lawsuits say the drug’s makers defectively designed the drug because it greatly increases the risk of hypophosphatemia.

The drug has been on the market since 2013, but drugmakers only added a warning to the label in 2020. People say that the warning added in 2020 is inadequate for patients and medical providers.

Plaintiffs claim physical, emotional, and financial damages.

Defendants include Luitpold Pharmaceuticals Inc., American Regent Inc., and Daiichi Sankyo.

What is Injectafer?

Injectafer is a prescription intravenous iron replacement medication for adults with iron deficiency anemia who don’t do well with oral iron supplements.

Injectafer Class Action Lawsuit or Mass Tort?

If you have been injured by Injectafer Iron Injection, you may be able to file a lawsuit. It is important to know that lawsuits involving medical drugs or devices are usually not filed as class actions, even if many people have been hurt by the drug or device.

Class action lawsuits are when many people have the same type of damages, usually economic damages. Mass tort lawsuits are when many people are injured, but the injuries are different.

Injectafer Side Effects

Injectafer, a drug used to treat iron deficiency anemia, may cause common side effects such as nausea, dizziness, and pain or bruising at the injection site. Serious side effects of this medication can include high blood pressure, allergic reactions, and abnormally low phosphate levels.

Common Side Effects of Injectafer

According to the drug’s prescribing information, clinical trials studied its safety and effectiveness in 1,775 patients who received Injectafer.

Side effects and percentage of people who reported them in clinical trials include:

  • Constipation
  • Dizziness
  • Altered taste
  • Erythema (skin redness)
  • Flushing
  • Headache (including migraines)
  • Hypertension
  • Hypophosphatemia (HPP)
  • Hypotension
  • Increased hepatic enzymes
  • Injection site discoloration
  • Injection site reactions
  • Nausea
  • Rash
  • Vomiting

Voluntary reports to the FDA Adverse Events Reporting System (FAERS) list 4,858 total adverse event cases related to Injectafer — including 3,411 severe reactions and 138 deaths as of March 31, 2021.

Serious Injectafer Side Effects

Injectafer severe side effects include allergic reactions, high blood pressure and iron overload.

Allergic Reactions

People who take Injectafer may have a serious, life-threatening allergic reaction. This can cause low blood pressure, shock and loss of consciousness. If this happens, it could lead to death.

After receiving an infusion, providers monitor patients to watch for signs of a reaction.

High Blood Pressure

4% of patients who received Injectafer during clinical trials reported high blood pressure, sometimes accompanied by dizziness, facial flushing or nausea.

Iron Overload

If you receive too much Injectafer, it may lead to iron overload. Iron overload happens when there is too much iron in the body. This can increase the risk of diabetes, liver disease, osteoarthritis, hypothyroidism, osteoporosis, heart failure and/or heart attack.

If you experience any of the following symptoms, speak to your doctor: skin color changes, a metallic taste in your mouth, blood in your stool, abdominal pain, hair loss, infertility, depression, chronic fatigue or joint pain.

Other Serious Side Effects

According to the drug’s prescribing information, other reported serious side effects to include:

  • Difficulty breathing
  • rash
  • rapid heartbeat
  • itching
  • chest discomfort
  • fever
  • chills
  • swelling of the face, lips, or tongue
  • muscle aches and back pain
  • fainting

What Is Hypophosphatemia?

Hypophosphatemia is a condition where a person has abnormally low phosphate levels.

Abnormal in adult blood tests means a phosphate level of less than 2.5 mg/dl.

In February 2020, Injectafer’s manufacturer added a warning to the drug’s label for symptomatic hypophosphatemia.

In some studies, researchers have found that Injectafer is more likely to cause hypophosphatemia than other iron replacements such as oral iron supplements.

Mild cases of hypophosphatemia don’t usually have symptoms.

More severe HPP symptoms include:

  • Bone pain
  • Muscle weakness
  • Fatigue
  • Heart problems
  • Seizures
  • Disorientation

Several patients have filed an Injectafer lawsuit after suffering severe and prolonged hypophosphatemia.

Lawsuits claim drug manufacturers failed to warn the public about the risk adequately.

Did you develop hypophosphatemia or other serious side effects after receiving Injectafer? 

Severe HPP
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Severe HPP is a rare condition that can be inherited or caused by medical conditions in adulthood. Still, some studies have linked ferric carboxymaltose, Injectafer’s active ingredient, to a severe drop in phosphorus levels.

Schaefer et al., PLoS One Study

A study published in PLoS One in 2016 found that Injectafer was associated with a 20-fold higher risk of HPP than iron Monofer.

18 of the cases studied were severe HPP and some of those were even life-threatening.

In contrast, only one patient who took iron isomaltoside suffered from a mild case of HPP.

Myles Wolf and other researchers published a study in 2018 that found that 50.8 percent of 1,000 patients who took Injectafer developed HPP, while only 0.9 percent of 997 patients who took Feraheme (ferumoxytol) did.

FDA Denied Injectafer Approval Twice

In addition, the U.S. Food and Drug Administration denied Luitpold’s new drug application for Injectafer in 2006 and again in 2008 for clinical safety concerns.

FDA did not initially approve Injectafer because of safety concerns, including:

  • More patients who took Injectafer versus controls died
  • More serious adverse events occurred in patients who took Injectafer versus oral iron
  • Clinically important hypophosphatemia

In 2015, the FDA issued a warning letter to Luitpold for attempting to promote Injectafer for unapproved uses and for presenting misleading claims about the drug in a video ad.

Is There a Recall for Injectafer Infusions?

Despite studies linking Injectafer to hypophosphatemia, the FDA had not issued a recall for the drug.

Injectafer Iron Infusions Procedures

  • The old procedure is a two-dose course of treatment for 1,500 mg.
  • The agency approved a new single-dose injection of 1,000 mg of Injectafer in May 2021.

Symptoms of Hypophosphatemia

Mild cases of hypophosphatemia in adults don’t usually cause symptoms. But prolonged severe hypophosphatemia can result in serious symptoms such as seizures or heart failure.

HPP symptoms include:

  • Bone pain and fractures
  • Coma
  • Difficulty breathing or shortness of breath
  • Fatigue
  • Heart arrhythmias
  • Heart failure and/or heart attack
  • Irritability
  • Mental confusion or delirium
  • Muscle pain
  • Muscle weakness
  • Respiratory failure
  • Seizures
  • Softening of the bones

Reasons to File an Injectafer Lawsuit

Plaintiffs who file an Injectafer lawsuit may do so to hold Luitpold and other drug manufacturers accountable for failing to warn people about the risk of HPP.

Plaintiffs may also receive compensatory damages for physical, emotional and financial losses caused by an HPP diagnosis and treatment.

Compensation may cover:

  • Decreased ability to earn a living because of fatigue, brain fog, pain or other symptoms of HPP
  • Future medical bills for chronic HPP and lifelong phosphate supplementation
  • Lost business or professional opportunities
  • Lost quality of life, suffering and mental anguish
  • Lost wages from hospitalizations or doctor’s appointments resulting from HPP, may include family members’ lost wages
  • Medical expenses for diagnosis and treatment of HPP
  • Spouse’s loss of companionship

Who Can File a Lawsuit?

Anyone who had at least one administration of Injectafer in 2013 or later and suffered from symptoms of hypophosphatemia may contact an attorney for a free case review.

Only an experienced attorney can tell you if you qualify to file a lawsuit.

If you suffered the following injuries after taking Injectafer, you might qualify to file a lawsuit for compensation:

  • Acute renal failure
  • Cardiac arrest or failure
  • Cardiac arrhythmias or dysrhythmias
  • Death
  • Drop-in blood phosphorus
  • Hypophosphatemia or Severe Hypophosphatemia
  • Osteomalacia (softening of the bones)
  • Renal Wasting
  • Respiratory Failure
  • Rhabdomyolysis (muscle breakdown)
  • Severe muscle fatigue or weakness
  • Severe or extended pain

Family members who lost loved ones because of severe HPP after taking Injectafer may qualify to file a wrongful death claim. There are time limits to file a claim, depending on the state.

Contact an Injectafer Lawyer to discuss your options.

Severe HPP
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Sources: Lawsuit & Study