Results of two new clinical trials appear to confirm concerns surrounding Injectafer side effects, especially a link to dangerously low phosphorous levels.
Injectafer is an intravenous medication used to treat people suffering from iron-deficiency anemia who can’t tolerate or who haven’t responded well to oral iron supplements.
The U.S. Food & Drug Administration (FDA) approved Injectafer (ferric carboxymaltose) in 2013, after previously rejecting the medication because of a potential association with “excess mortality and severe hypophosphatemia.”
Since then, however, several studies have suggested Injectafer is more likely to cause dangerously low phosphorous levels compared to alternative IV iron treatments. A growing number of Injectafer lawsuits also claim the drug’s manufacturers had long been aware of this risk, but wrongly represented the medication as a safe and effective treatment for iron-deficiency anemia without providing adequate warnings to patients and doctors.
The results of these latest trials were published in the February issue of the Journal of the American Medical Association (JAMA). Together, the studies involved 245 patients with iron-deficiency anemia, all of whom received either 750 mg of Injectafer on day 0 or 1000 mg of Monofer (iron isomaltoside) on days 0 and 7. The patients were followed for 45 days.
Data from the trials also suggested even a single dose of ferric carboxymaltose could adversely impact an individual’s entire skeleton, providing a possible explanation for other potential Injectafer side effects, including osteomalacia and bone fractures.
Severe hypophosphatemia occurs when the amount of phosphorous in the blood falls below 1mg/dL). Symptoms typically include:
If hypophosphatemia goes untreated, victims may experience respiratory failure, muscle weakness, cardiac arrest, seizures, coma, and even death.