Injectafer Iron Injection Lawsuit
Patients with iron deficiency anemia who are considering treatment with injectable iron supplements should be aware of a serious side effect associated with one of them—Injectafer. Manufactured by American Regent, the treatment has been linked to severe hypophosphatemia, a condition in which blood levels of phosphorus drop to a dangerously low level. Symptoms may include seizures, respiratory failure, and even fatal arrhythmias.
The lawyers at Chaffin Luhana handle cases nationwide with offices in Pittsburgh, New York City, and West Virginia are investigating cases in which Injectafer caused dangerous side effects. Meanwhile, if you or a loved one was treated with Injectafer, it’s important to watch carefully for symptoms like muscle weakness, bone pain, tingling and numbness, and confusion. If you experience these symptoms, check with your doctor right away.
Injectafer Linked with Risk of Severe Hypophosphatemia
Several scientific studies have indicated that Injectafer can increase risk of hypophosphatemia (HPP) and severe hypophosphatemia. Both of these conditions occur when there are low levels of phosphate in the blood.
Phosphate is a combination of the mineral phosphorus and oxygen. Many of the foods we eat in our daily diets contain phosphorus. This nutrient is very important in the body, as it’s involved in the following processes:
- repairing bones and teeth,
- helping metabolize carbohydates and fats
- making protein for the growth, maintenance, and repair of cells and tissues
- supporting healthy muscles and muscle contractions
- making ATP, a molecule the body uses to store energy
- maintaining a normal heartbeat
- maintaining a normal kidney function
- supporting nerve signaling
When phosphate levels drop below normal, difficult symptoms may develop. At mild and moderate levels, symptoms may include:
- Muscle weakness
- Bone pain, bone fractures
- Rhabdomyolysis (destruction of muscle cells)
- Tingling, numbness, tremors
Severe HPP is much more dangerous, and in some cases can be life-threatening. It is a rare condition because phosphorus is present in so many foods, so most people usually get enough. But studies have indicated that some patients can experience this condition after being injected with Injectafer.
Symptoms of severe HPP may include:
- Muscle wasting
- Respiratory failure
- Acute hemolytic anemia (a condition in which red blood cells are destroyed too quickly)
- Fatal arrhythmias (heart rhythm abnormalities)
Studies Show Injectafer Increases Risk of Severe Hypophosphatemia
A number of studies have shown that Injectafer, more than other forms of injectable iron, can increase risk of both HPP and severe HPP. Below are the details:
- In 2013, researchers found that FCM (the form of iron used in Injectafer) lowered phosphate levels, with effects persisting for three months.
- In 2015, Researchers reported that among 130 patients treated with iron preparations, 52 received iron sucrose and 78 received FCM. Only 22 percent of those treated with iron sucrose developed HPP, while 51 percent of those treated with FCM did. And 13 percent of those developed severe HPP. The researchers wrote, “Hypophosphatemia is frequent after parenteral FCM injection, and may have clinical consequences, including persistent fatigue.”
- In 2016, Researchers compared FCM and another iron supplement called iron isomaltoside. They found that the risk of HPP was greater after an injection of FCM compared with iron isomaltoside (IIM). In fact, only those injected with FCM suffered from severe HPP. More specifically, a surprising 45.5 percent of those injected with FCM suffered from HPP, and 32.7 percent suffered from severe HPP. Researchers concluded that treatment with FCM “is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.” They added that the risk was “substantially lower” with the other iron supplement.
- 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 2017 letter to the editor, doctors revealed that HPP had been described to occur in up to 70 percent of patients treated with FCM.
Mild and moderate forms of HPP can be treated with phosphate supplementation, whereas more severe forms are treated with phosphate injections.
Types of Injuries Associated with Injectafer
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
What is Injectafer?
Injectafer is an injectable iron supplement made up of ferric carboxymaltose (FCM). This form of iron consists of a ferric hydroxide core stabilized by a carbohydrate shell. The injection is used to help relieve symptoms of iron deficiency anemia in patients who have not responded well to other treatments. The injections can deliver up to 1,500 mg or iron in two doses, spread out over at least seven days. Appropriate dosage, however, depends on weight.
Unlike oral iron supplements, which are commonly used to treat iron deficiency anemia, an iron injection can deliver the nutrient directly into the bloodstream, and thus produce more immediate results. After it’s administered into the vein, it gradually releases iron, helping patients to feel better quickly.
Doctors use Injectafer in patients who either experienced poor results from oral iron supplements, or who were unable to tolerate them for some reason, often because of digestive troubles. The injection is also used to treat iron deficiency anemia in patients with chronic kidney disease who are not receiving dialysis.
The FDA approved the use of Injectafer to treat iron deficiency anemia in July 2013. At the time, it was the first “high-dose non-dextran” IV iron supplement meant to treat the condition.
- “High-dose” meaning that it delivered a high dose of iron as compared to oral supplements.
- Non-dextran referring to the fact that unlike older iron supplements made of iron dextran, Injectafer didn’t contain dextran, which was associated with a higher risk of allergic reactions.
After the product had been on the market a few years, however, studies began to question its safety for some patients.
What is Iron Deficiency Anemia?
Iron deficiency anemia is a condition in which blood levels of iron are low, resulting in “anemia”—low hemoglobin levels. The body needs the mineral iron in order to make enough red blood cells. Inside those red blood cells is a substance called “hemoglobin.” This substance binds to oxygen and helps carry it around the body to the organs and tissues that need it.
That means if the body is low on iron, it’s not going to be able to make as many red blood cells. As levels of red blood cells drop, so do levels of hemoglobin. Without enough hemoglobin, the body tissues and organs don’t get the oxygen they need to operate optimally, and that can cause problems.
At mild levels, iron deficiency anemia may present no noticeable symptoms. As it gets worse, however, patients may notice the following:
- Extreme fatigue
- Pale skin
- Cold hands and feet
- Brittle nails
- Headache, dizziness, lightheadedness
- Chest pain
- Shortness of breath
- Poor appetite
- Unusual cravings for items like dirt and ice
Those more at risk for iron deficiency anemia include older individuals, those with a family history of the disorder, vegetarians, those who give blood regularly, endurance athletes, women with heavy menstrual periods, and pregnant women.
The condition can range from mild to severe. At mild levels, treatment usually includes oral iron supplements and dietary changes. If the condition goes on untreated or undiagnosed, however, it can become severe. When that happens, patients are at risk for the following complications:
- Heart problems, including irregular heartbeats (arrhythmias), heart murmurs, an enlarged heart, or even heart failure
- Increased risk of infections
- Cognitive difficulties or delays (particularly in children)
- Pregnancy complications
Treatment for iron deficiency anemia usually involves oral iron supplements. The treatment is effective, but it can take three-to-six months to restore iron levels to normal. If these supplements don’t work as expected, or if patients have other conditions (digestive disorders, kidney disease, celiac disease), doctors may recommend iron supplement injections instead, to more quickly increase iron levels in the blood. Those who have severe iron deficiency anemia may also need red blood cell transfusions, to replenish the red blood cells in the body.
According to a 2013 study, iron deficiency anemia affects two percent of adult men, 9-12 percent of non-Hispanic white women, and nearly 20 percent of black and Mexican-American women. That means thousands of people deal with this disorder, and many of those may be treated with Injectafer.
Yet Injectafer manufacturers do not warn about the danger of possibly developing severe HPP. They state that patients may experience “mild” side effects like headaches and nausea, and that they may suffer from a decrease in blood phosphorus levels, but they give no indications of how serious that decrease could be.
Those who have been treated with Injectafer and then suffered from HPP or severe HPP are likely to believe that this warning label, at the very least, is inadequate. Manufacturers are responsible for making sure that both doctors and patients are aware of the risks before taking any sort of treatment, yet in this case, American Regent seems to be leaving important information out of their product labeling.
We are actively investigating potential Injectafer iron injection lawsuits. Patients in the Pittsburgh and Ohio Valley areas who have taken this product and then experienced serious side effects may be able to recover damages in an Injectafer lawsuit. Call today for a free case evaluation at 1-888-316-2311.