| Project Title | Antiepileptic Drugs (AEDs) and Kidney Stones 2 |
| Date Posted | Tuesday, September 23, 2014 |
| Project ID | MSY4_MPR55 |
| Status | Complete |
| Deliverables | |
| Description | 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. |
| Medical Product | anti-epileptic drug (AED) carbamazepine gabapentin lamotrigine levetiracetam oxcarbazepine phenytoin topiramate valproic acid zonisamide |
| Health Outcome | kidney stone |
| Time Period | January 1, 2004 - December 31, 2012 |
| Assessment Type | Exploratory Analyses |
| Study Type | Modular Program |
| Data Sources | Mini-Sentinel Distributed Database (MSDD) |
| FDA Center | CDER |
