Exposure to Intravenous (IV) Iron Procedures and Anaphylaxis and Epinephrine Events

Basic Details
Date Posted
Friday, March 2, 2018
Medical Product
intravenous (IV) iron
Health Outcome(s)
epinephrine event

Mini-Sentinel's IV Iron Workgroup requested execution of Modular Program #3 (MP3) to investigate exposure to IV iron procedures and anaphylaxis and epinephrine events for individuals with and without a pre-existing condition of dialysis. This involved one run of MP3. The time window for the request is January 1, 2000 – December 31, 2012. The package was distributed to Data Partners on January 17, 2013.

Additional Details
FDA Center
Time Period
January 1, 2000 - December 31, 2012
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
All individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)