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, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, [Stanford- Juan?], Martijn Schuemie.

Coordinating Institution(s): Regenstrief Institute / Georgia Tech

Participating Institution(s): Regenstrief Institute, Georgia Tech, Janssen Research and Development, Columbia University, University of California Los Angeles, University of Texas Houston, Stanford University, QuintilesIMS.

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.