Parenteral Iron and Anaphylactoid Reactions

Basic Details
Date Posted
Friday, July 22, 2016
Medical Product
parenteral iron (IV iron)
Health Outcome(s)
anaphylactoid reaction

This protocol will guide a one-time assessment of the association between parenteral iron products and anaphylactoid/anaphylactic reactions. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

This protocol was posted for public comment from September 4, 2013 through September 18, 2013. The public comment period is now closed. A revised version was approved for implementation by FDA on January 8, 2014. A log of changes is included in the revised protocol (v2.0).

Additional Details
FDA Center
Time Period
2000 - 2012
Study Type
Protocol/Surveillance Plan
Assessment Type
Safety Analyses
HOI Study Type
Validations Supported by Traditional Medical Chart Review
Population / Cohort
All non-dialysis individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Workgroup Leader(s)

Kathleen Walsh MD, MSc; Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

Cunlin Wang MD, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Susan Andrade ScD; Joann Wagner MSW; Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, MA 

Maryam Asgari MD, MPH; Kaiser Permanente Northern California, Oakland, CA

Irene Fung MD; Peter Reese MD, MSCE; University of Pennsylvania School of Medicine, Philadelphia, PA

Monika Houstoun PharmD, MPH; Robert Kane MD; Mark Levenson PhD; Marsha Reichman PhD; Qin Ryan MD, PhD; Diqiong Xie PhD, MS; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Lingling Li PhD; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Gayathri Sridhar PhD, MBBS, MPH; HealthCore Inc., Wilmington, DE