A new warning has been added to the label of the intravenous iron injection Injectafer, regarding the potential for the iron deficiency anemia treatment to cause hypophosphatemia, a condition characterized by a dangerously low level of phosphate in the blood. Symptoms of hypophosphatemia (HPP) may include trouble breathing, muscle weakness, extreme fatigue and loss of appetite, and if left untreated, the disorder can lead to serious, potentially life-threatening complications like seizures, softening of the bones (osteomalacia), rhabdomyolysis or coma. If you or someone you know has developed hypophosphatemia and suffered one or more of these complications after receiving an Injectafer injection, do not hesitate to seek legal guidance from an Injectafer injury attorney. Depending on your specific situation, you may be able to pursue financial compensation for your injuries from American Regent and Luitpold Pharmaceuticals, the companies responsible for Injectafer in the United States.
Injectafer (ferric carboxymaltose) is an iron carbohydrate complex injection used to treat a common type of anemia called iron deficiency anemia. As the name implies, iron deficiency anemia is caused by insufficient iron in the body and in people with this condition, the body cannot get the oxygen it needs to function properly. Injectafer is a two-dose intravenous iron replacement drug designed to be injected directly into the vein, and it works by gradually releasing iron into the bloodstream. Unfortunately, a growing body of evidence suggests that while Injectafer can effectively treat iron deficiency anemia, it can also drastically reduce the amount of phosphate in the blood, possibly leading to hypophosphatemia. In people who develop hypophosphatemia, the phosphate level in the blood falls dangerously low, possibly leading to complications like respiratory failure, seizures, rhabdomyolysis, osteomalacia, heart failure, coma or even death.
In February 2020, the FDA finally updated the Injectafer drug label to include a warning about the possibility of patients who receive Injectafer suffering from hypophosphatemia side effects. The drug label now reads:
Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.
This new Injectafer warning label comes after years of studies have linked the IV iron therapy to an increased risk of hypophosphatemia in users. As early as 2013, research indicated that Injectafer could lower phosphorous levels in patients, and subsequent studies have concluded that Injectafer is more likely to cause severe hypophosphatemia than other IV iron therapies. In one study published in 2016, researchers found that 45% of patients treated with Injectafer developed hypophosphatemia and 32% developed severe hypophosphatemia, compared to 4% and 0% of patients treated with Monofer (iron isomaltoside), respectively. The researchers wrote, “Treatment with [ferric carboxymaltose] is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored.” A more recent study published in February 2020 reported that hypophosphatemia occurred in 75% of patients who received Injectafer, compared to only 7.9% of patients who received an iron infusion drug called Monoferric (ferric derisomaltose). Severe hypophosphatemia occurred in 11.3% of patients in the study who were treated with Injectafer and 0% of patients treated with Monoferric.
Medical evidence dating back several years has found that some iron therapies are associated with hypophosphatemia due to a decrease in the level of phosphate in the blood. However, the probability of developing hypophosphatemia and the severity of the disorder appears to be substantially higher among patients treated with Injectafer than among those treated with other IV iron therapies. And while the new Injectafer drug label states that most cases of hypophosphatemia are resolved within three months, the risk of serious and sometimes fatal complications associated with hypophosphatemia should not be overlooked. If you or someone you know has developed hypophosphatemia and suffered a serious medical complication like respiratory failure, cardiac arrest, seizure, osteomalacia or coma, contact an experienced Injectafer injury attorney as soon as possible to discuss your options for legal recourse.