Reply to McCulley et al., reports to FDA of fatal anaphylaxis associated with intravenous iron products

AND PETER WALDRON* U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of Pharmacovigilance and Epidemiology, Silver Spring, Maryland Additional Supporting Information may be found in the online version of this article. Conflict of interest: Nothing to report. *Correspondence to: Peter Waldron, MD, Medical Officer, Division of Pharmacovigilance II, Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, MD. E-mail: peter.waldron@fda.hhs.gov Received for publication: 28 July 2016; Revised: 8 August 2016; Accepted: 8 August 2016 Published online: 10 August 2016 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ajh.24531