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Levetiracetam and Risk of Angioedema in patients with Seizure Disorder
Objective: To assess the risk between exposure to Keppra (levetiracetam) and angioedema.
Rationale: The Food and Drug Administration (FDA) has recently announced that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health.
Project Lead(s): Jon Duke, Patrick Ryan, Marc Suchard, Martijn Schuemie
Coordinating Institution(s): Regenstrief Institute
Additional Participants (currently seeking additional collaborators):
- George Hripcsak
Any interested collaborators please contact Jon Duke at jonduke@regenstrief.org and I will be happy to add you to the collaborator list.
Participating Institution(s): Regenstrief Institute, Janssen Research and Development, Columbia University, University of California, Los Angeles
Full Protocol: Keppra and Angioedema Risk Protocol
Initial Proposal Date: 5/3/2016
Launch Date: TBD
Receive Results for Analysis Date: TBD
Study Closure Date: TBD
Results Submission: Email or SFTP
Customizable OHDSI-Formatted IRB
Requirements
CDM: V4 or V5 (both versions fully tested)
Table Accessed: CONDITION_OCCURRENCE, CONDITION_ERA, CONCEPT, PERSON
Database Dialects: SQL Server, Postgres, Oracle
Software: SQL and R
Code
Discussion
Datasets Run
- Columbia University - CUMC/NYP
- Taipei Medical University
- Ajou University School of Medicine
Waiting for Datasets From
- Stanford University
- University of Colorado
- University of California, Los Angeles
- Possibly - Children's Hospital of Philadelphia
- Possibly - Erasmus University Medical Center
