A growing number of lawsuits accuse the manufacturers of Injectafer® of failing to warn about the risk of hypophosphatemia, a severe side effect involving dangerously low phosphate levels in the blood.
The first lawsuits were filed in 2019, following studies in which Injectafer was linked to a possible risk of hypophosphatemia.
More lawsuits have been filed since February 2020, when the FDA ordered drug-makers to add “symptomatic hypophosphatemia” to the list of potential side effects on the label for Injectafer.
The FDA warnings were based on multiple clinical trials confirming that Injectafer posed an increased risk of hypophosphatemia.
For example, in one of the clinical trials, 75% of patients on Injectafer developed hypophosphatemia, compared to just 8% of patients on another iron injection called Monoferric. Furthermore, the clinical trial found that 11.3% of Injectafer patients in the study developed severe hypophosphatemia, compared to zero patients on Monoferric.
Severe hypophosphatemia is a life-threatening condition. The symptoms include extreme fatigue, cardiac arrest, respiratory failure, heart failure, irregular heart rhythm, coma, and death.
One of the most recent lawsuits was filed in April 2020 by Christa C., a woman from Idaho with iron-deficiency anemia who was treated with Injectafer in March 2016. Unfortunately, she soon developed hypophosphatemia.
Her health problems were so severe, she could not work for 10 weeks. Her symptoms included chest pain, heart palpitations, shortness of breath, insomnia, bone and joint pain, and a general deterioration of her health.
Her lawsuit — and many others in recent months — accuse Daiichi Sankyo and other drug-makers of failing to warn about the risk of hypophosphatemia from Injectafer, or the potential risk of devastating long-term health problems.
The lawsuit was filed on April 24, 2020 in the U.S. District Court for the Eastern District of Pennsylvania — Case No. 2:20-cv-02019.
Source: Wolf M, et al., Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials, JAMA. 2020; 323(5)423-443 (Feb. 2020).