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Following numerous iron infusions with Injectafer, a South Carolina indicates she developed severe medical condition involving persistently low phosphate blood levels, according to allegations raised in a product liability lawsuit filed against the drug manufacturer.
Teresa Edwards filed the complaint (PDF) in the U.S. District Court for the Eastern District of Pennsylvania on January 7, alleging that Daiichi Sankyo, Luitpold Pharmaceuticals, Relypsa, Inc. and Vifor Pharma failed to provide adequate warnings about the side effects of Injectafer infusions, which has been linked to reports of severe hypophosphatemia (HPP).
Injectafer (ferric carboxymaltose) was introduced in 2013, as an iron infusion for adults with anemia, who are not able to be treated with an oral iron supplement and have non-dialysis dependent chronic kidney disease. However, problems after an Injectafer infusion have included reports of severe HPP, which can result in severe health complications, including cardiac arrest, respiratory failure and death.
According to the lawsuit, Edwards was prescribed Injectafer in March 2018 for the treatment of iron deficiency anemia, and received a total of 10 infusions between March 2018 and May 2020, before she developed severe and symptomatic HPP. As a result of the Injectafer infusions, Edwards alleges she has suffered, and will likely suffer in the future, from a number of ailments, including severe muscle fatigue and weakness, as well as severe and persistent pain.
Injectafer is the only anemia treatment on the U.S. market which contains a unique ferric carboxymaltose (FCM) compound, which is known to cause severe HPP and potentially persistent HPP. The lawsuit claims the manufacturers knew about these risks but failed to warn the medical community or patients being given the injections.
“Defendants could have designed Injectafer more safely. For example, they could have designed the drug to have a lower single and maximum dose, in order to lessen the risk of adverse events, particularly the risk of Severe HPP and its resulting injuries,” Edwards’ lawsuit notes. “Defendants also have a duty not to manufacture, market, and sell a product that is unreasonably dangerous so that its potential harm outweighs its potential benefits. Defendants have breached their duty to ensure safe, well-tested, well-monitored, and properly labeled products enter into the pharmaceutical market.”
Edwards claims the manufacturers failed to provide adequate label warnings, which should have alerted doctors and patients to the risk of severe HPP, as well as the injuries it can cause, including osteomalacia, rhabdomyolysis, cardiac arrest, cardiac arrhythmia and respiratory failure.
The case joins a growing number of other Injectafer infusion lawsuits filed over the past year, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.