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