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Injectafer Overview
Injectafer (also known as ferric carboxymaltose) is an intravenous medication used to treat iron deficiency anemia. Iron deficiency anemia affects about 7.5 million people in the U.S., and involves inadequate body iron stores for normal red blood cell production. IDA is a common complication for a variety of GI disease conditions.
After an infusion of the drug, Injectafer releases iron into the body in order to help alleviate anemia and anemia symptoms. Injectafer is manufactured by Daiichi Sankyo and was approved by the U.S. Food and Drug Administration (FDA) in 2013.
Injectafer’s FDA approval came with some restrictions, however, due to Injectafer side effects. It is meant to be used only for anemia patients who have not responded well to oral iron supplement, who couldn’t tolerate oral iron supplements at all, or who had non-dialysis dependent chronic kidney disease. Injectafer is usually given in two doses every seven days by appointment.
Injectafer Infusion Time
As an injection-based medication, Injectafer has a set infusion schedule. A single dose of Injectafer, up to 750 mg, can be administered without dilution through an IV push injection at a rate of 100 mg/minute. It can also be administered via an IV infusion in a dosage of up to 250 mL 0.9% Sodium Chloride Injection USP over a period of at least 15 minutes.
When Will I Feel Better After Injectafer?
As with any medication, Injectafer comes with a few minor side effects. These side effects include:
- Nausea
- Dizziness
- High blood pressure/general changes in blood pressure
- Flushing
- Low phosphorus levels
- Vomiting
- Headache
Patients taking Injectafer may wonder: when will I feel better after an Injectafer infusion? These kinds of mild side effects often go away on their own within a few days, and sometimes within a couple of weeks. But if these complications worsen or don’t go away, this is a good sign that it’s time to talk to your doctor or pharmacist.
Unfortunately, not all Injectafer side effects are so mundane.
Severe Injectafer Side Effects
More severe Injectafer complications can include issues like high blood pressure, high iron levels, and severe hypophosphatemia (HPP).
High blood pressure can be quite serious, leading to severe headaches, a “pounding” in the neck or ears, dizziness, and nausea, and can even in the most severe cases lead to life-threatening complications such as a heart attack or a stroke.
High iron levels can carry symptoms like a metallic taste in the mouth, bloody stools, vomiting blood, chest pain, severe shortness of breath, and more. In the most severe instances, patients experiencing high iron levels may lose consciousness or suffer a seizure.
Hypophosphatemia—or low phosphate levels—can cause weakness, trouble breathing, and loss of appetite. In babies, it can potentially cause rickets. More severe cases of hyphophosphatemia can be life-threatening, leading to seizures, respiratory failure, acute hemolytic anemia (destruction of red blood cells), and heart arrhythmias. Indeed, the mortality rate of HPP is quite high. Injectafer appears to cause hypophosphatemia at a much higher level than competing drugs, and reportedly carries the risk of causing severe HPP.
Some people may also experience serious allergic reactions or seriously low phosphorus levels.
Injectafer Approval History
What is Injectafer’s approval history with the FDA? It was actually a long process to get Injectafer FDA approval. The company first tried to get the drug approved back in May 2007, but the FDA questioned its safety and decided not to approve Injectafer in March 2008 due to concerns for women suffering from heavy bleeding due to an “imbalance of deaths observed in controlled trials” when compared to those taking iron pills.
In 2011, the company tried for approval once again, and again, the FDA withheld that approval in 2012. The long sought-after approval finally came in 2013.
Lawsuits Filed Over Injectafer Side Effects
Some patients have already come forward with litigation over Injectafer complications.
In Jan. 2020, a Florida woman filed her lawsuit against American Regent Inc. and its parent company Luitpold Pharmaceuticals, along with Daiichi Sankyo and Vifor Pharmaceuticals, alleging her three Injectafer injections in April and May 2019 caused her to develop severe hypophosphatemia that landed her in the emergency room. Even though she has since been released and was fortunately able to avoid fatal complications, she says, she has continued to experience unstable phosphate levels, causing ongoing symptoms including headaches, severe fatigue, shortness of breath, labored breathing, heart palpitations, a racing heartbeat, and gastrointestinal issues.
According to the lawsuit, the manufacturers of the drug knew about the risk of severe hypophosphatemia for years—even before they sought FDA approval.
