We thank Dr Cachat and colleagues for their interest in our article and for the valuable information they are reporting. We tried to conduct an unbiased systematic review, but we are aware of the shortcomings of using published results of randomized, controlled trials (RCTs) to report severe adverse events: severe events are too rare to be captured by RCTs (this is why we included all trials on intravenous iron), recording of adverse events might be less rigorous and more biased than that of the primary outcome in such studies, the patients included in RCTs might not be representative of the patients given the drug in clinical practice, and for some medications, the time frame for identifying the adverse events might be the wrong one.
Postmarketing surveillance adds valuable information, but we should remember that it lacks comparison, and some of the patients given iron have severe underlying disorders. Further, the quality of the reported data might be problematic.
As clinicians, we need to weigh all available data when offering intravenous iron to our patients, and the postmarketing surveillance should be part of these data.
© 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.