No Injectafer recall has been announced, despite consumer concerns surrounding serious Injectafer side effects which could result in death.

What Is Injectafer?

Injectafer is an intravenous ferric carboxymaltose medication used to treat iron deficiency anemia. Anemia means there is a lack of red blood cells. As the condition’s name implies, iron deficiency anemia is caused by too little iron leading to a low number of red blood cells.

Typically, people get iron through their diet or supplementation. However, some people have low iron levels and resulting anemia despite a balanced diet and supplementation. In these cases, Injectafer may be used for treatment.

The drug includes colloidal iron (III) hydroxide in complex with a carbohydrate polymer known as carboxymaltose. Together, these Injectafer ingredients work to treat iron deficiency anemia by releasing iron into the blood stream.

Injectafer treatments are given through an IV. The treatment has two doses – each given seven days apart. However, if anemia continues despite treatment, additional rounds of Injectafer may be required.

What Side Effects Are Caused by Injectafer Ingredients?

Unfortunately, Injectafer ingredients may induce severe side effects, including the following:

• Severe hypophosphatemia.
• Muscle dysfunction/weakness.
• Mental status changes.
• White blood cell dysfunction.
• Respiratory failure.
• Rhabdomyolysis.
• Acute renal failure.
• Osteomalacia.
• Cardiac arrhythmia or dysrhythmias.
• Cardiac arrest or failure.
• Death.

One of the more concerning side effects reported with Injectafer is severe hypophosphatemia. Hypophosphatemia, or HPP, refers to low levels of phosphate in the blood.

There are several causes of HPP, varying from genetics to medications. The consequences of HPP typically vary depending on the cause. For example, chronic hypophosphatemia can be associated with brittle bones and other skeletal problems.

The sudden onset HPP reported with Injectafer treatment may have severe symptoms such as altered mental state, seizures, numbness, reflexive weakness, muscle pain, muscle weakness, and even cardiac problems like heart failure. If left untreated, severe hypophosphatemia can lead to death. In fact, some studies have reported the mortality rate of hypophosphatemia to be as high as 73%.

Is There An Injectafer Recall?

As of November 2020, there is no Injectafer recall in effect despite reports of severe side effects. However, the medication was given a stronger warning label in February 2020 to warn patients and doctors of the risk for “symptomatic hypophosphatemia.” Initial labeling for the drug referenced only “transient” or “asymptomatic” hypophosphatemia.

Although the manufacturer and U.S. Food and Drug Administration (FDA) have not initiated a recall, this has not stopped legal action from allegedly injured consumers.

Legal action against Injectafer manufacturers contends that the companies – including Luitpold Pharmaceuticals, Daiichi Sankyo, Vifor Pharmaceuticals, and more – misrepresented their medication as safe and effective.

A lawsuit by plaintiff Celeste W. says that these misrepresentations have real consequences. Celeste was reportedly prescribed Injectafer in December 2014 for the treatment of iron deficiency anemia. After six total injections, Celeste allegedly started to experience “critically” low levels of phosphate. After seeking medical attention, she was reportedly diagnosed with severe hypophosphatemia due to phosphate wasting.

“Her records indicate that this diagnosis was induced by the administration of Injectafer,” the Injectafer lawsuit alleges. “She was forced to undergo routine and regular monitoring of her phosphorous levels.”

Celeste has allegedly sustained significant symptoms as a result of the Injectafer side effects, including abnormal EKGs, severe chest pain, vertigo, chronic pain, joint swelling, “crippling” bone pain, muscle aches, weakness, numbness, and fatigue. This has allegedly lead to difficulty walking, difficulty using her hands, sleep disturbances, and emotional pain.

According to Celeste’s lawsuit, the drug manufacturers knew that their product could be associated with dangerous hypophosphatemia. As early as 2016, studies reportedly showed that ferric carboxymaltose – the type of iron used in Injectafer – was riskier than another iron option – iron isomaltoside 1000.

In a 2016 study, the ferric carboxymaltose was reportedly associated with a 20 fold higher risk than iron isomaltoside. In fact, all 18 cases of “severe and life threatening” hypophosphatemia in the study were seen in the Injectafer group.

Despite these results, manufacturers allegedly continued to market their medical as safe and effective. Celeste contends that these representations were misleading and unlawful.

Can I File an Injectafer Class Action Lawsuit?

Although no Injectafer recall has been initiated, consumers may still have options if they experienced adverse side effects. If you experienced Injectafer side effects such as hypophosphatemia, you could be eligible to take legal action.

The Injectafer Lawsuit is Case No. 2:19-cv-03914 in the U.S. District Court for the Eastern District of Pennsylvania.