Recent studies suggest Injectafer may be more likely to cause severe hypophosphatemia (dangerously low serum phosphorus levels) compared to other intravenous iron supplements. An Injectafer lawsuit may allow victims of the potentially deadly side effect to obtain compensation for medical bills and other injury-related damages.
The defective drug attorneys at Bernstein Liebhard LLP are offering free, no-obligation legal reviews to anemia patients who were diagnosed with severe hypophosphatemia following Injectafer infusions.
To learn more about filing an Injectafer lawsuit, please contact our office today at (888) 994-5118 to arrange for your free, no-obligation case review.
Injectafer (ferric carboxymaltose injection) is an intravenous iron supplement product indicated to treat adults with iron deficiency anemia who:
The U.S. Food & Drug Administration (FDA) initially declined to approve Injectafer in 2008, after premarket clinical trials identified “excess mortality and severe hypophosphatemia” as possible safety risks.
When the agency finally approved Injectafer to treat iron deficiency anemia in 2013, it restricted its use to the indications noted above.
That same year, a study published in BMC Nephrology reported that 47 chronic kidney disease patients had exhibited “significant decreases” in serum phosphorus levels three weeks after receiving a single dose of Injectafer to treat iron deficiency anemia. The levels remained low 12 weeks after their infusion
Since then, a growing body of research has suggested that Injectafer is more likely to cause severe hypophosphatemia compared to other injectable iron supplements.
For example, an Austrian study published in 2016 found that hypophosphatemia occurred in 45% of patients treated with Injectafer, while 32% developed severe hypophosphatemia. At the same time, hypophosphatemia was observed in just 4% of the patients treated with Monofer, and none experienced severe hypophosphatemia.
Most recently, in a clinical trial involving 2,000 anemia patients, more than half (50.8%) of those participating in the study’s Injectafer arm developed severe hypophosphatemia. However, the rate of hypophosphatemia among Feraheme patients was less than 1%.
The nation’s first Injectafer lawsuit involving hypophosphatemia was filed in the U.S. District Court, Eastern District of Pennsylvania, on January 18, 2019, less than one month after those findings appeared in the Journal of Clinical Investigation. (Case No. 2:19-cv-00276-WB).
Barely two years after its approval, Luitpold Pharmaceuticals received an FDA Warning Letter in connection with promotional video that made misleading claims about Injectafer and minimized its risks. The video apparently aired during a Lifetime Network TV special, The Balancing Act, in December 2014.
Among other things, the video suggested Injectafer could be used to treat all patients with iron deficiency anemia, including children, even though it’s approved indications are limited to adult patients who can’t use oral iron or those with non-dialysis dependent chronic kidney disease.
The FDA also criticized the video for presenting side effect information in small, difficult-to-read text that appeared at the bottom of the screen for roughly 30 seconds. Apparently, the videos’ audio continued during that presentation. The videos’s dialogue also addressed associated with other anemia treatments, but failed to disclose that Injectafer is associated with many of the same issues.
“This presentation is misleading because it implies that Injectafer offers advantages (both therapeutic and non-therapeutic) over other currently approved treatments, when this has not been demonstrated,” the agency said. “FDA is not aware of any evidence to support the implication that Injectafer offers significant advantages over other prescription drugs already approved for this condition.”
Hypophosphatemia is an electrolyte disturbance that occurs when serum phosphorus levels fall below < 2.5 mg/dL. The condition is considered severe when serum phosphorus is lower than 1.0 mg/dl.
Risk factors associated with hypophosphatemia include:
Patients with mild hypophosphatemia may not experience any signs of a phosphorous deficiency. However, severe hypophosphatemia does cause noticeable symptoms, including:
Without treatment, severe hypophosphatemia can lead to:
Adding more phosphorous-rich foods, including milk or other dairy products, is often enough to treat mild hypophosphatemia. These patients may also benefit from oral phosphorus supplements, while those deficient in vitamin D will need to take those supplements as well.
In most cases, severe hypophosphatemia is only reversed via intravenous phosphorous supplementation.
Anemia patients who suffered severe hypophosphatemia after Injectafer treatments may be entitled to financial compensation for all of their injury-related damages, including:
To discuss filing an Injectafer lawsuit with a member of our legal team today, please fill out the form on this page or call our office directly (888) 994-5118.
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