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

Basic Details
Date Posted
Status
Complete
Medical Product
intravenous (IV) iron
Health Outcome(s)
anaphylaxis
epinephrine event
Description

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.

Deliverables (4)
Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 1 Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 2 Mini-Sentinel Modular Program Report: IV Iron and Anaphylaxis Report 3 Mini-Sentinel Modular Program Report: IV Iron and Epinephrine Report 4
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - December 31, 2012
Analysis Type
Mini-Sentinel
Population / Cohort
All individuals
Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Links
Parenteral Iron and Anaphylactoid Reactions