| 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. 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. |
| 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 |
