Injectafer is an intravenous medication prescribed to patients with iron deficiency anemia. Scientific research suggests that Injectafer patients are at high risk of developing hypophosphatemia, a condition that can result in severe health complications. Sanders Phillips Grossman is filing lawsuits against manufacturers for failure to warn about this dangerous and potentially deadly Injectafer side effect.
As a nationally-recognized defective drug law firm, Sanders Phillips Grossman has been holding pharmaceutical companies accountable for over 30 years. If you experienced symptoms of hypophosphatemia—including confusion, weakness, or an irregular heartbeat—following Injectafer therapy, contact us for a complimentary case evaluation.
What is Injectafer?
Iron helps in the production of red blood cells. Anemic patients do not produce enough red blood cells, which deliver oxygen throughout the body. There are many forms of anemia. Iron deficiency anemia (IDA) is the most common form, affecting an estimated 7.5 million Americans.
Injectafer (ferric carboxymaltose) is an iron replacement product indicated for the treatment of IDA in adult patients. The Food and Drug Administration (FDA) approved Injectafer (manufactured by American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals Inc.) in July 2013. Two doses are administered intravenously by a doctor at least 7 days apart. Treatment may be repeated if the patient’s IDA recurs.
Medicinal iron is available as oral as well as intravenous (IV) therapy. IV iron therapy has a number of formulations, including iron sucrose, ferric gluconate, ferumoxytol, ferric carboxymaltose, and iron dextran. Injectafer is indicated for a “broad patient population,” according to American Regent. Outside of North America, Injectafer is sold as Ferinject by Vifor Pharma.
Injectafer Linked to Severe and Extreme Hypophosphatemia
The safety and efficacy of Injectafer were evaluated in two clinical trials consisting of more than 11,071 patients treated either with the drug or a competitor. Injectafer’s manufacturer says that, “This represents the largest safety database ever submitted to FDA to support the approval of an IV iron product.”
Post-approval research, however, has found that use of ferric carboxymaltose (i.e., Injectafer) results in the incidence of severe hypophosphatemia at much higher rates than the competition.
Hypophosphatemia (HPP) is an abnormally low level of phosphate in the blood. Phosphate—a type of electrolyte—plays a number of key functions in the body, such as energy production, nerve function, and healthy bones. HPP is measured by serum levels of phosphate concentration, and can be diagnosed as mild, moderate, severe, or extreme.
A study published recently in the Journal of Clinical Investigation (JCI) found significantly higher incidence of HPP in patients given Injectafer compared to patients given ferumoxytol (a different type of iron therapy injection). Specifically, the incidence of severe and extreme HPP was 50.8% among the Injectafer patient group, compared to 0.9 % for the ferumoxytol group.
In other words, treatment with ferric carboxymaltose induced HPP in more than half of all patients studied. According to the researchers, HPP was detectable within 1 week of Injectafer administration, peaked in frequency by week 2, and lasted through the end of the 5-week study in nearly one-third of patients.
Symptoms and Side Effects of Hypophosphatemia (HPP)
Although mild and moderate cases of HPP typically do not produce symptoms, severe and extreme cases can lead to symptoms that include:
- Appetite loss
- Bone pain
- Bone fractures
- Muscle weakness
- Tooth decay
Left untreated, HPP can lead to serious complications such as respiratory failure, cardiac arrest, coma, bone weakening, death of muscle tissue, seizures, and death.
Did American Regent Fail to Warn About Injectafer and Severe Hypophosphatemia?
Drugs are not expected to be completely safe, but manufacturers have a legal duty to warn about the side effects of their drugs so that doctors and consumers can make informed treatment decisions.
Injectafer prescribing information mentions hypophosphatemia under “Adverse Reactions.” It also describes hypophosphatemic osteomalacia (HPP-related bone softening) occurring in patients receiving unusually-high doses of Injectafer.
But nowhere does Injectafer prescribing information mention the “severe” or “extreme” HPP cases found in the above-mentioned JCI study. Importantly, that study administered Injectafer at the FDA-approved dosage. Furthermore, as that study notes, hypophosphatemia had already developed in more than 20% of patients after they received a half-dose of ferric carboxymaltose.
American Regent boasted about the size of their safety database, yet despite this robust data, the drugmaker was apparently unable—or unwilling—to draw the connection between Injectafer and severe HPP.
FDA Warned Manufacturer About Downplaying Injectafer Risks
In 2015, the FDA sent a warning letter to Luitpold Pharmaceuticals about improperly marketing Injectafer. The warning applied to Injectafer video marketing materials that the FDA says provided inadequate directions for use, minimized the drug’s risks, and omitted material facts.
FDA wrote that the video, “fails to discuss any risks associated with Injectafer…Therefore, this presentation is misleading.” FDA additionally rebuked Luitpold for suggesting that “treatment with Injectafer can drastically improve the general well-being of a patient with IDA.” Finally, FDA said it was not aware of any evidence to support the implication that Injectafer offers significant advantages over other prescription drugs already approved to treat IDA.
While this raises the question of why FDA would approve a drug without significant advantages over existing IDA drug, it also calls into question whether Luitpold/American Regent is willing to bend the truth to gain a market advantage.
Receive a Free Injectafer HPP Lawsuit Evaluation
Anyone who took Injectafer as prescribed and suffered harm from HPP side effects may be eligible for a lawsuit against the drug’s manufacturers.
Sanders Phillips Grossman has a strong track record of successfully taking on the pharmaceutical industry. We’ve held leadership positions in some of the largest drug litigations in U.S. history, and recovered more than one billion dollars for our clients. To discuss an Injectafer lawsuit with an attorney, free of charge, please call 1-800-530-9800 or contact us online.