A North Carolina woman claims to have developed dangerously low phosphorus levels after undergoing multiple Infectafer treatments for iron deficiency anemia.
Injectafer (ferric carboxymaltose) was introduced in the United States in 2013. Prior to that, the medication was marketed in Europe under the name Ferinject.
According to an Injectafer lawsuit filed in the U.S. District Court, Eastern District of Pennsylvania, on August 29th, Celeste White has suffered from iron deficiency anemia since 2014. She received her first Injectafer treatment in December of that year, and subsequently went on to receive five additional infusions. (2:19-cv-03914)
Following her Injectafer treatments, White’s phosphate levels dropped to critically low levels indicative of severe hypophosphatemia. As a result, she began receiving intravenous and oral phosphate treatments.
White was ultimately diagnosed with severe hypophosphatemia, allegedly as a consequence of her Injectafer treatments.
White’s Injectafer lawsuit claims that the drug’s manufacturers were aware of case reports and case series indicating some intravenous-iron patients develop severe and symptomatic hypophosphatemia. Multiple studies have also suggested that patients treated with Injectafer are more likely to develop severe hypophosphatemia than those who receive other intravenous iron products.
Yet the Injectafer label makes only a passing reference to hypophosphatemia as a possible side effect, and makes no mention of severe hypophosphatemia at all.
“The Defendants intentionally, recklessly, and maliciously misrepresented the safety, risks, and benefits in order to advance their own financial interests, with wanton and willful disregard for the rights and health of the Plaintiff,” the complaint states.
“As a proximate result of the Defendants’ marketing, promotion, labeling, sale and/or distribution of Injectafer, Plaintiff has been injured catastrophically, and sustained severe and permanent pain, suffering, disability, and impairment, loss of enjoyment of life, loss of care, comfort, and economic damages,” the lawsuit continues.
Severe hypophosphatemia occurs when phosphate levels drop below 1mg/dL. Symptoms may include:
If untreated severe hypophosphatemia can also result in respiratory failure, muscle weakness, cardiac arrest, seizures, coma, and even death.