Ferric carboxymaltose injection receives FDA approval for iron deficiency anaemia in heart failure

There were no new safety signals. The most common treatment-emergent adverse events were nausea, headache, injection site reactions, hypertension, dizziness, and hypophosphatemia. 

According to the manufacturer, American Regent, ferric carboxymaltose injection has been studied in more than 40 clinical trials that included more than 8800 patients worldwide and has been approved in 86 countries.

International guidelines already recommend screening for iron deficiency in heart failure and support intravenous iron repletion: the most recent European Society of Cardiology heart failure guidelines (but not the most recent US guidelines) specify that intravenous ferric carboxymaltose can be considered to prevent further heart failure admissions in symptomatic patients recently hospitalized.

“This new indication for Injectafer marks the first and only FDA approval of an IV iron replacement therapy for adult patients with heart failure,” American Regent Chief Medical Officer Ravi Tayi, MD, MPH, said in the press release. “This latest approval continues to build on the effective and proven use of Injectafer for adult and pediatric patients with iron deficiency anaemia, and now for adult patients with heart failure who have iron deficiency.”