Hypophosphatemia Is An Injectafer Side Effect With Possible Medical Complications Leading To Hospitalization Or Death
Injectafer (ferric carboxymaltose) is an iron replacement injection approved by the FDA in 2013 for the treatment of iron deficiency anemia (IDA) in certain patients as an alternative to oral iron medications. Injectafer-induced hypophosphatemia (HPP) is an Injectafer side effect causing muscle weakness, fatigue, and severe nausea. In turn, these hypophosphatemia symptoms can lead to Injectafer-related medical complications including osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and rhabdomyolysis.
Injectafer is one of several intravenous iron supplements available for use in the US, but Injectafer is the only iron deficiency drug product formulated with ferric carboxymaltose (FCM). According to medical studies, the Injectafer active ingredient ferric carboxymaltose can cause two types of this hypophosphatemia side effect: (1) Severe Hypophosphatemia, or Severe HPP; and, (2) Persistent Hypophosphatemia, or Persistent HPP.
In more detail, hypophosphatemia is an electrolyte disturbance that is found when a patient's blood tests reveal that there is an abnormally low level of phosphate. There are several levels of hypophosphatemia: mild hypophosphatemia; moderate hypophosphatemia; and, severe hypophosphatemia. In addition, there can be persistent hypophosphatemia when a patient suffers from hypophosphatemia for a sustained period of time.
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Medical case reports indicate that some patients getting iron injection treatments will develop hypophosphatemia. What distinguishes Injectafer from other intravenous iron supplements, however, are medical research studies showing a significantly higher rate for ferric carboxymaltose use resulting in a hypophosphatemia diagnosis. Put otherwise, it appears that the ferric carboxymaltose -- found only in Injectafer -- causes an increased risk of hypophosphatemia. Accordingly, hypophosphatemia is diagnosed more often after Injectafer injections are given, i.e., Injectafer-induced hypophosphatemia, compared to when iron deficiency anemia patients receive other iron injection treatments.
Despite this medical evidence regarding Injectafer-induced hypophosphatemia, there is little if any warning about hypophosphatemia being a serious Injectafer side effect to be found anywhere in the Injectafer Prescribing Information, or drug label (accessed 2/3/2020).
This failure to warn about Severe HPP in the Injectafer drug label is the legal basis for patients diagnosed with hypophosphatemia after getting their Injectafer injection treatments to file drug injury lawsuits against the pharmaceutical companies responsible for Injectafer.
As mentioned above, severe hypophosphatemia can cause Injectafer-related medical complications including but not limited to:
- Cardiac Arrest
- Respiratory Failure
We are investigating possible drug injury lawsuits involving Injectafer side effects for patients who are diagnosed with hypophosphatemia following an Injectafer iron injection treatment and thereafter develop Injectafer-related medical complications.
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