Injectafer is a medication that is used to treat iron deficiency anemia. These intravenous iron treatments are meant to help people who cannot take or tolerate oral iron deficiency supplements.
However, Injectafer was known to be dangerous even before it was approved by the FDA Now, an additional safety concern with phosphate in the blood has sometimes caused serious issues for up to half the people who have taken Injectafer.
If you or a loved one have been harmed, you may be able to file an Injectafer lawsuit against Luitpold Pharmaceuticals, the company that makes Injectafer.
Adult Iron Deficiency Anemia
Adult iron deficiency anemia is a common condition. Roughly five million adults in the United States suffer from this condition. Iron deficiency anemia is when the blood lacks adequate red blood cells.
This comes from an iron level that is too low, and it may come from a condition causing a significant decrease, such as chronic kidney disease or chemotherapy. In most cases, the iron deficiency anemia (IDA) patients are able to take oral iron supplements.
Symptoms of Iron Deficiency Anemia
Iron deficiency anemia in adult patients can range from mild to severe.
- Severe fatigue
- An inflamed or sore tongue
- Cold hands and feet
- Pale skin
Injectafer to Treat Iron Deficiency Anemia
Not all adults with iron deficiency anemia can take iron supplements. These oral supplements can have serious side effects that make them dangerous for some patients who have medical conditions.
Other patients have kidney disease and need an iron injection instead of taking supplements. Finally, some patients may have taken oral supplements that simply did not work.
Injectafer is a prescription strength iron supplement that helps people who are at a high risk of developing side effects from iron supplements such as:
- Chest pain
- Bloody stool
- Abdominal cramping
Injectafer Iron Injections
Some patients will tolerate treatment far better if it is an injectable iron supplement. This is why Injectafer is on the market. The drug is manufactured by American Regent. The company is a subsidiary of Luitpold Pharmaceuticals. In turn, Luitpold Pharmaceuticals is owned by the Japanese company Daiichi Sankyo Group.
Injectafer was the first and only high-dose non-dextran intravenous iron for the treatment of iron deficiency. The drug was approved by the Food and Drug Administration in 2013.
After FDA approval, Injectafer racked up high annual sales. Even after a 6% drop in sales due to negative publicity, Injectafer still did over $400 million in annual sales in the U.S. in 2020. There has been recent FDA approval of a single-dose version of Injectafer
Food and Drug Administration Safety Concerns
Even before the FDA approved this drug, the agency had some serious safety concerns. FDA approval came six years after the makers of the drug first applied for approval. The drugmaker first tried for approval for use in patients with heavy bleeding and inflammatory bowel disease.
However, Luitpold Pharmaceutical tried and failed twice to get full approval for ferric carboxymaltose.
The second rejection happened after the FDA found "issues'' at Luitpold Pharmaceuticals manufacturing plant.
The company had to go through the drug application process three times before the FDA approved Injectafer because of the agency's clinical safety concerns about the drug.
Conditions on FDA Approval
The FDA gave conditional approval to Injectafer. The agency only approved ferric carboxymaltose subject to three conditions:
- It was only for patients who could not take oral supplements
- It could only be used by patients who had a reaction to oral supplements
- It could only be used by patients with kidney disease that did not require dialysis
How Are Patients Treated With Injectafer?
As its name implies, Injectafer is given to patients intravenously. An Injectafer injection will happen in your doctor's office.
Doctors will administer the drug directly to the vein of Injectafer patients in one of two ways:
- A slow intravenous drip that will take 15 or more minutes
- An IV push that gives the required dosage in eight minutes
In some cases, the course of treatment is given as one injection. Other patients will need two doses spread seven days apart to get the necessary dosage.
How Intravenous Iron Injections Work
The other name for Injectafer is ferric carboxymaltose. This compound is an iron carbohydrate complex in an injectable form. It is used to treat various forms of anemia by raising iron levels.
The concept behind ferric carboxymaltose seems relatively simple. It is just supposed to be a form of iron supplement for those who cannot tolerate the oral dose.
The Serious Risks Associated With Ferric Carboxymaltose (Injectafer)
The usual side effects of Injectafer include:
- High blood pressure
- Injection site reactions
- Hot flashes
Here, the major issue with Injectafer is that it has been shown to cause severe hypophosphatemia in patients.
This is a dangerous condition that must be immediately treated. This is why the makers of the products are now the defendants in numerous Injectafer lawsuits.
Hypophosphatemia is when there is a low phosphate level in the blood. Phosphate performs a valuable function in the human body.
Phosphorus combines with oxygen in your body to make phosphate. Roughly 85% of the phosphate in your body is found in your bones.
Specifically, phosphate does the following:
- Helps your body build bones
- Produces energy for your body
- Builds strength in your muscles
The levels of phosphate in your body cannot be too high or too low. In other words, blood phosphate levels must be perfectly calibrated.
Severe HPP happens when your phosphate level drops far below what your body needs to perform the above functions.
Symptoms of Severe HPP
Severe HPP can be life-threatening. At a very minimum, it will impact your daily life, especially since you need phosphate to have the energy that you need.
Here are some of the symptoms of severe hypophosphatemia:
- Muscle weakness
- Severe muscle fatigue
- Decreased levels of energy
- Weakening of the bones
- Bone pain
- Joint pain
- Altered mental state
In addition, there are also symptoms that can lead to death in instances of severe hypophosphatemia. Because the muscles and the body are weakened, the respiratory system can be affected. This can eventually lead to respiratory failure.
When patients have severe hypophosphatemia, respiratory failure happens because of a lack of energy substrate at the cellular level. Muscle dysfunction then causes respiratory failure.
Further, patients with severe HPP can also suffer from seizures that can also be life-threatening. Finally, severe HPP can also cause cardiovascular events. This includes heart failure and fatal arrhythmias (heart attacks).
Injectafer Causes Severe and Prolonged Hypophosphatemia
Patients have been filing adverse event reports with the FDA describing the severe side effects that they have experienced from Injectafer.
In total, the number of these reports is nearing 5,000. Some of the adverse event reports have detailed severe HPP, while others have described the exact side effect that was caused by the Injectafer.
Many of these detail instances of respiratory failure and cardiovascular events.
Studies Linking Injectafer With Hypophosphatemia
Several academic journals have documented the high risk of developing severe and serious adverse reactions to Injectafer. Researchers have studied the effects of ferric carboxymaltose, mostly taking statistical samples of patients who have been treated with Injectafer.
The Journal of Rheumatology was the first to study some of the effects of Injectafer. They found that approximately half of patients treated with Injectafer will suffer from severe HPP.
This was followed by other studies that found roughly similar rates of severe hypophosphatemia as patients who were receiving the treatment. At this point, numerous medical journals have all reached the same conclusion.
One recent study shows the full extent of the problem. BMC Medicine published an analysis that showed that 75% of women who were treated with ferric carboxymaltose suffered from some form of hypophosphatemia.
The rates of hypophosphatemia from Injectafer compared to those of other iron treatments (like iron isomaltoside) are far higher.
Severe hypophosphatemia is treated by addressing the underlying cause of the condition. Here, the issue is that the Injectafer has already been administered, so healthcare providers will need to focus on raising phosphate levels.
Of course, the patient should stop further Injectafer treatments while the severe HPP is being addressed, and their doctor will probably take them off the treatment.
Some options for raising phosphate levels in the body include:
- Dietary phosphate
- Oral phosphate products
- An IV phosphate treatment
The problem is that severe HPP can cause sudden side effects that may not be able to be stabilized before they cause long-term damage. Phosphate levels can fall quickly, and the symptoms can have sudden onset.
Injectafer's Makers Failed to Warn the Public
The increased risk of HPP was not a secret to Luitpold Pharmaceuticals. However, they failed to adequately warn the public of these dangers.
The drug's warning label is silent about the severe hypophosphatemia risk associated with Injectafer. Adequate warnings would have alerted the public to the risk of severe and prolonged HPP.
Injectafer was approved by the FDA in 2013 after a six-year process. During that time, there were research studies that showed cases of severe HPP linked with an injectable iron treatment in a kidney transplant patient.
Even if this was not from Injectafer itself, the makers of the product should have been on notice that severe HPP was a possibility after use of Injectafer, and they should have alerted both the FDA and the general public.
Instead, this product was sold without a warning label for over five years after study after study documented the raised risk of hypophosphatemia from using Injectafer. In the meantime, the makers of Injectafer raked in billions of dollars in annual sales of the drug while patients were sickened.
The FDA Orders Adequate Warnings
After years of American Regent ignoring the serious risks to the public, the FDA finally took action. In February 2020, the agency ordered Injectafer's maker to amend its warning label on the drug.
Now, the drug's warning label was to carry a mention of "symptomatic hypophosphatemia.” However, there were scores of patients who developed severe side effects without any prior knowledge because the manufacturer failed to warn of them.
Sales of Injectafer have fallen slightly after the FDA ordered the warning labels on the drug, as healthcare providers have considered other options for treating iron deficiency.
There have been a number of Injectafer lawsuits filed in federal court filed by people who suffered severe hypophosphatemia (hpp). The first of these cases are about to go to trial.
They are currently in court in the Eastern District of Pennsylvania. We expect the number of cases to grow in the near future given the number of adverse event reports that have been filed with the FDA.
Depending on the outcome of these initial cases, the product's manufacturer may attempt to settle the rest of the cases. If you have been injured and have not filed an Injectafer lawsuit of your own yet, this is the time to speak with a drug recall attorney.
Damages in Injectafer Lawsuits
You may be entitled to the following damages in an Injectafer lawsuit if your case is successful:
- Medical expenses
- Lost wages
- Pain and suffering
- Emotional distress
- Wrongful death if your loved one passed away from complications from intravenous iron induced hypophosphatemia
How much you may receive depends on your own particular damages in your case. Of course, more severe cases will lead to higher payouts.
Call an Injectafer Lawyer
Law firms are filing lawsuits against Daiichi Sankyo Inc. and American Regent Inc. for their clients developing severe and prolonged HPP as a result of these dangerous drugs.
If you or a loved one have been injured, you may have grounds for a court case for Injectafer injuries. Drug companies and makers of defective medical devices must pay when their product harms you.
However, you should see a lawyer now to file an Injectafer lawsuit before the statute of limitations expires.
Call the attorneys at Rosenfeld Injury Lawyers to learn more about a possible Injectafer lawsuit that could lead to financial compensation from Luitpold Pharmaceuticals and its parent company.
We will learn the facts of your injury and discuss your legal options during a free case evaluation. This free case review will outline your path forward and explain the many lawsuits Injectafer has sparked.
Call us today at (888) 424-5757 or fill out an online contact form to set up a time to talk about your case.