New Use of Anti-Epileptic Drugs and Agranulocytosis

Project Title New Use of Anti-Epileptic Drugs and Agranulocytosis
Date Posted
Tuesday, June 21, 2016
Project ID
to09y05_mpr_wp38_v01
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of diagnoses of agranulocytosis, Absolute Neutrophil Count (ANC) laboratory results, and agranulocytosis diagnoses within 14 days of an ANC result following new use of several anti-epileptic drugs. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to June 30, 2013. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information. Queries were distributed in August 2014. This report includes data from 10 Data Partners.
 
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Medical Product
anti-epileptic drug (AED)
carbamazepine
lamotrigine
levetiracetam
topiramate
Health Outcome
absolute neutrophil count (ANC)
agranulocytosis
Time Period
January 1, 2006 - June 30, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER
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