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, George Hripcsak, Christian Reich, Yuri Khoma, Marie-Sophie Schwalm, …… more pending

Coordinating Institution(s): Regenstrief Institute / Georgia Tech

Additional Participants (currently seeking additional collaborators):

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: 5/18/2016

Receive Results for Analysis Date: 7/15/2016

Study Closure Date: 12/1/2016 (Study closed)

Results Submission: Via the OHDSI Sharing module embedded in study or via Email.