Antiepileptic Drugs (AEDs) and Kidney Stones

Project Title Antiepileptic Drugs (AEDs) and Kidney Stones
Date Posted
Tuesday, January 7, 2014
Project ID
MSY4_MPR29
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of incident use of eight antiepileptic drugs (lamotrigine, levetiracetam, topiramate, carbamazepine, oxcarbazepine, zonisamide, gabapentin, and phenytoin) and a diagnosis of kidney stones.  Each product was analyzed by two unique incidence definitions and two unique kidney stone definitions. The queries were run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2004 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 4.0; click here for more information. Queries were distributed in April/May 2013. These reports include data from 18 Data Partners.

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Medical Product
anti-epileptic drug (AED)
carbamazepine
gabapentin
lamotrigine
levetiracetam
oxcarbazepine
phenytoin
topiramate
zonisamide
Health Outcome
kidney stone
Time Period
2004-2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER