Safety

Q. Historically, there has been an association of anaphylaxis with the use of IV iron. What risk is there of that here?

A. The original intravenous iron preparations were an iron dextran. Dextran has resulted in anaphylaxis due to preformed antibodies in the human body. Ferinject® is iron carboxymaltose. This means it has a carbohydrate outer shell which removes this risk. However, there have been rare reports of ‘anaphalactoid’ reactions and so all intravenous iron preparations remain under the same guidance – staff will still need to have resuscitation equipment available when using Ferinject® as it is currently still in the same MHRA category as other iron preparations. Event reporting with Ferinject® is significantly lower than transfusion and there is no difference in the rate of events when compared with placebo in the randomised controlled trials reported to date (over 13,000 patients).

 

Q. What risk is there of sepsis with the use of iron?

A. Chronic iron overload may predispose to infections due to its toxic effects on cells and tissues. It may also be detrimental to the body’s response against infection as shown in Sub-Saharan Africa where iron supplementation has been associated with increased Malaria risk.  However, with an acute iron injection, there is no evidence of increased infection rates. The IV iron will be gone from circulation within 48 hours and therefore not have an effect in the following few weeks when the patient is undergoing surgery. There is no evidence of increased infections in patients with renal disease or IBD who routinely receive IV iron therapy.

 

If you need to unnblind a patient at anypoint during the study, please call 0808 168 2544