A Florida woman indicates she suffered severely low phosphate levels after receiving an Injectafer iron infusion, according to allegations raised in a recently filed product liability lawsuit against Daiich Sankyo and other drug makers.
The complaint (PDF) was filed late last month by Alice Oakley in the U.S. District Court for the Eastern District of Pennsylvania, indicating the intravenous injection administered to treat iron deficiency carries serious side effects which were not adequately disclosed by the drug maker.
Injectafer (ferric carboxymaltose) was introduced by Daiichi Sankyo 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, side effects of Injectafer have ben linked to reports of serious and life-threateningly low phosphorous levels, known as severe hypophosatemia (HPP).
Oakley indicates she suffered from iron deficiency anema (IDA) since about 2006, and was prescribed Injectafer iron infusions in April 2019. After three injections, each about one week apart, she began to suffer critically low levels of phosphorous. As a result, she was treated in the emergency room, where she was given IV phosphate infusion, but her phosphate levels remained unstable and she was ultimately diagnosed with severe hypophatemia, which has left her with severe and permanent injuries, according to the complaint.
Oakley’s lawsuit names Luitpold Pharmaceuticals, Inc., American Regent, Inc. Daiichi Sankyo, and Vifor Pharmaceuticals Management as defendants, indicating the companies knew for years that Injectafer could cause severe hypophosphatemia, or Severe HPP, but failed to provide adequate warnings to consumers or the medical community.
“Defendants at no times have attempted to warn users of these risks and have therefore violated their duties to warn and not misrepresent the benefits of a drug,” according to the complaint. “Defendants also have a duty to explain to the medical community how to properly investigate and monitor sharp drops in phosphorous levels. Defendants at no time have provided such warnings.”
The case joins a growing number of other Injectafer lawsuits filed in recent months, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.