TabsDetailsBasic DetailsDate Posted: Tuesday, September 23, 2014Status: CompleteMedical Product: anti-epileptic drug (AED), carbamazepine, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, topiramate, valproic acid, zonisamideHealth Outcome(s): kidney stoneDescription: Modular program-based one-time assessment of incidence of kidney stones following new use of anti-epileptic medications among all exposed patients and among those with a pre-existing condition of epilepsy and those with an exclusion of pre-existing anti-diabetic agent exposure. The query was run against the Mini-Sentinel Distributed Database (MSDD) for a time period of January 1, 2004 – December 31, 2012. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 5.0; click here for more information. Queries were distributed in August 2013. This report includes data from 18 Data Partners.If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer. Read More Deliverables (2)Mini-Sentinel Modular Program Report: AEDs & Kidney Stones 2 Report 1Mini-Sentinel Modular Program Report: AEDs & Kidney Stones 2 Report 2Additional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2004 - December 31, 2012Study Type: Modular ProgramAssessment Type: Exploratory AnalysesData Sources: Mini-Sentinel Distributed Database (MSDD)
