Iron deficiency anemia is a condition in which the body doesn’t have enough red blood cells to properly transport oxygen to the body’s tissues. Patients may feel tired, out of breath, and weak, and may suffer from headaches, cold hands and feet, brittle nails, and even chest pain.
Oral iron supplements taken over a period of several weeks usually resolve the problem but some patients can’t wait that long, or they’re unable to tolerate the oral supplements.
In these cases, doctors often recommend an iron infusion like Injectafer (ferric carboxymaltose), which is an injectable form of iron that is delivered straight into the bloodstream. It acts quickly, helping patients to get all the iron they need usually within a week, while easing symptoms of iron deficiency anemia.
In some cases, however, these injections are dangerous. Recent studies have shown that instead of benefitting from a treatment with Injectafer, certain patients will instead develop severe hypophosphatemia (HPP), a condition that can cause life-threatening complications.
Unfortunately, the manufacturer—American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc. (a Daiichi Sankyo Group Company)—has not provided adequate warnings about this risk.
We are currently investigating cases in which patients with iron deficiency anemia were treated with the iron injection “Injectafer” and suffered from serious injuries.
Hypophosphatemia (HPP) Cause by Injectafer Iron Infusion
Since Injectafer came onto the market, there have been many reports of people receiving the treatment, and then suffering a dangerous condition known as hypophosphatemia (HPP). Patients might feel weak after the treatment, or experience a rapid or irregular heartbeat. These are signs of HPP, which is a condition where the body becomes deficient in phosphate (phosphorus).
Usually HPP occurs only in people who are severely malnourished or who can’t absorb nutrients from their food, but scientific studies have found that it can occur in people receiving Injectafer treatments, too.
Phosphate is a combination of the mineral phosphorus—which we get from our diet—and oxygen. Foods rich in phosphorus include tuna, lean meats, dairy products, seafood, lentils, quinoa, squash, and many more. Usually getting enough phosphorus is not a problem, so most people are safe from HPP, unless they have iron deficiency anemia and something goes wrong with an Injectafer treatment.
Scientists aren’t sure why Injectafer may increase risk of HPP in some people, but they think it has to do with how the supplement may prevent the kidneys from reabsorbing phosphate. After an injection, it seems the body excretes more phosphate than it should through the urine, resulting in a deficiency.
HPP can range from mild to severe. Mild cases may not cause any symptoms at all, but more moderate or severe cases will. Symptoms may include:
- Muscle weakness
- Bone pain, bone fractures
- Irritability and apprehension
- Numbness or tingling, tremors
Patients who have any of the following may be more at risk for HPP:
- Complications of diabetes (diabetic ketoacidosis)
- Kidney disorders
- Chronic diarrhea
- Vitamin D deficiency
- Long-term use of drugs like diuretics, antacids, corticosteroids, and others
Injectafer Linked with Severe Hypophosphatemia (HPP)
Not only has Injectafer been linked with HPP, it’s also been linked with severe HPP, which can be a life-threatening condition. This occurs when phosphate levels become dangerously low. If left untreated, complications like the following may develop:
- Muscle wasting (Rhabdomyolysis)
- Respiratory failure
- Acute hemolytic anemia (a condition in which red blood cells are destroyed too quickly)
- Fatal arrhythmias (heart rhythm abnormalities)
Research has shown that severe HPP can increase risk of death by four-fold. At the time of this writing, Injectafer manufacturers had still not provided adequate warnings about the risk of this condition on their product labels, or anywhere on their product materials. Doctors and patients are left in the dark as to this potential danger.
Studies Show Injectafer Increases Risk of Severe Hypophosphatemia
For years, scientists have found evidence showing that the type of iron used in Injectafer, ferric carboxymaltose (FCM), can increase risk of HPP. Back in 2013, researchers looked at nearly 50 patients with chronic kidney disease who also had iron-deficiency anemia. The patients received a single injection of FCM, and their blood levels of phosphate levels dropped significantly for three weeks afterwards. They remained low at week 12.
In a 2016 study, researchers compared FCM and another iron supplement called iron isomaltoside. After examining data from 81 patients, they found that hypophosphatemia risk was greater with FCM (45.5 percent) compared to only 4 percent with iron isomaltoside. They also found that severe HPP occurred only in those treated with FCM, with a risk of 32.7 percent.
In a 2015 study, scientists looked at the medical records of patients who received iron injections between 2012 and 2014. Among those treated with FCM, 51 percent developed HPP, compared to only 22 percent in those treated with another type of iron supplement (iron sucrose). The scientists also found that the higher the dose of FCM, the more severe the HPP.
“Hypophosphatemia is frequent after parenteral FCM injection,” the researchers wrote, “and may have clinical consequences, including persistent fatigue.”
In another study, published in 2017, researchers again noted that results from clinical trials suggested a higher risk for HPP with certain types of iron injections, including ferric carboxymaltose. In a letter to the editor written that same year, doctors revealed that HPP had been described to occur in up to 70 percent of patients treated with ferric carboxymaltose.
Severe cases of HPP require intravenous phosphate treatment.
Potential Injectafer Related Injuries
Patients treated with Injectafer may be at risk for the following conditions:
- Severe hypophosphatemia
- Bone pain and fractures
- Seizures, coma
- Rhabdomyolysis (muscle wasting)
- Fatigue and muscle weakness
- Heart rhythm problems
- Acute hemolytic anemia
- Respiratory failure
Studies and adverse event reports show that Injectafer, more than other types of injectable iron supplements, can increase risk of both HPP and severe HPP. Yet the manufacturers have failed to provide adequate warnings about the risk to doctors and patients.
Chaffin Luhana attorneys are experienced in helping clients recover damages from negligent manufacturers. If you or a loved one received an Injectafer treatment and then suffered from severe HPP, we will fight to be sure you receive fair compensation. Call today for a free case evaluation at 1-888-316-2311.
Iron Deficiency Anemia FAQs
What is Injectafer?
Injectafer is an injectable form of iron (ferric carboxymaltose) that is used as a replacement product to quickly restore iron levels to normal. Because the iron is injected directly into the bloodstream, it doesn’t have to go through the digestive system, and 91-99% percent of it is absorbed. This can result in an accelerated cure for anemia. It can also help patients feel better quickly, while providing an alternative to oral supplements for patients who can’t tolerate them.
In July 2013, the FDA approved Injectafer to treat iron deficiency anemia in adult patients who have an intolerance or an otherwise inadequate response to oral iron. The product consists of ferric carboxymaltose (FCM) inside a carbohydrate shell, which helps slow breakdown so that the iron is gradually released into the system. One injection can provide up to 1,500 mg of iron in just two administrations separated by at least seven days, but the dosage is up to the doctor.
When the FDA first approved Injectafer, it was the first “high-dose non-dextran” intravenous iron supplement available to treat iron deficiency anemia. Older supplements with dextran were known to cause allergic reactions, so manufacturers capitalized on the fact that Injectafer was made without this ingredient.
Although doctors may have used Injectafer to help some people, other people have suffered serious health complications because of the product.
What is Iron Deficiency Anemia?
“Anemia” is a term describing a lack of healthy red blood cells. “Iron deficiency anemia” means that the anemia is caused by a shortage of the mineral iron. We need iron in the body to help remove carbon dioxide, make digestive enzymes, maintain healthy skin and hair, and support healthy cells. But iron’s most important job is to help transport oxygen throughout the body.
Iron is an important component of “hemoglobin,” which is the substance inside the red blood cells that actually carries the oxygen around. You breathe in oxygen, and the hemoglobin inside the red blood cells grabs it and helps get it to the other organs and tissues that need it. In fact, about two-thirds of the iron in your body is present in your hemoglobin.
If the body doesn’t have enough iron, it can’t make enough hemoglobin. Red blood cells without hemoglobin are not healthy, and cannot carry the oxygen around like they should. The more deficient you are, the less oxygen is delivered, and you’ll begin to suffer from symptoms of anemia.
There are other things that can cause anemia, but iron-deficiency is the most common cause worldwide. To prevent it, you need only get enough iron in your diet, which is usually not difficult. Many foods contain iron, including spinach, beans, lean beef, seafood, potatoes, dark chocolate, fortified breakfast cereals, tofu, fortified flour, nuts, and fortified grain products.
How Do I Know if I have Iron Deficiency Anemia?
If you’re only mildly deficient in iron, you probably won’t notice any symptoms. If your body doesn’t get the iron it needs and the anemia gets worse, however, symptoms may include:
- Extreme fatigue
- Muscle weakness
- Pale skin
- Dizziness and lightheadedness
- Cold hands and feet
- Accelerated heartbeat
- Shortness of breath
- Inability to concentrate or think clearly
- Brittle nails
- Unusual cravings for ice, dirt, paper, and starches
- Poor appetite
There are some factors that can put you more at risk for iron deficiency anemia. These include:
- Being female (women are more at risk since they menstruate every month)
- Pregnancy and breastfeeding
- Digestive diseases like Crohn’s disease and ulcerative colitis
- Peptic ulcer disease
How Serious is Being Anemic?
The seriousness of your condition depends on how much hemoglobin is missing, and how long you’ve been anemic. Mild levels of deficiency aren’t likely to cause long-term health problems, but more severe deficiencies can if they’re not treated properly.
If you experience symptoms like those noted above, check with your doctor. Treatment can reverse the situation most of the time. If you don’t get treatment and the anemia continues to get worse, the body may become starved for oxygen. Serious consequences may include organ failure, irregular heartbeat, and heart failure.
Do Iron Supplements Cause Side Effects?
Though many people tolerate iron supplements just fine, some people will experience side effects when taking them. These may include:
- Stomach upset
- Nausea, vomiting, diarrhea
- Dark schools
Adding additional fiber to the diet or taking supplements with food can help can help. It is also wise to start with a lower dose and then gradually increase to a higher one to minimize side effects.
How Much Iron Do You Need if You’re Anemic?
If you’re diagnosed with iron deficiency anemia, you’ll typically need more iron than you can get in your daily diet to restore iron levels to normal. This is usually accomplished through oral iron supplements or with iron injections.
Most people with iron deficiency anemia need 150-300 mg of iron per day, but the proper dosage depends on the severity of the deficiency, and your weight and age. Supplements are usually taken in pill form. They have to go through the digestive system, though, which means that only a small portion of the iron will be absorbed into the bloodstream. Vitamin C helps improve absorption, so many doctors will recommend that you take vitamin C supplements long with your iron pills or tablets.
Treatment with oral supplementation takes time. Your doctor will keep checking your iron levels as you go, and once they’re back to normal, he or she is likely to advise you to continue to take the supplements for awhile, up to several months after the initial treatment.
If you cannot tolerate oral supplements, or if your symptoms are severe and you need a faster, more potent treatment, your doctor may recommend iron injections.