Drugs that Act on the Renin-Angiotensin-Aldosterone System (Angiotensin Converting Enzyme Inhibitors, Angiotensin Receptor Blockers, Aliskiren) and Angioedema

Basic Details
Date Posted
Thursday, October 18, 2012
Status
Complete
Medical Product
aliskiren
angiotensin II receptor blocker (ARB)
angiotensin-converting enzyme (ACE) inhibitor
Health Outcome(s)
angioedema
Description

Protocol-based one-time assessment of the risk of angioedema associated with new use of drugs that act on the renin-angiotensin-aldosterone system (RAAS), including angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), and aliskiren. The assessment concerned individuals aged ≥18 years who initiated oral ACEIs, ARBs, aliskiren or beta-blockers. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

Workgroup Leader(s)

Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Sean Hennessy PhD, PharmD; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Marsha E. Reichman PhD; Monika Houstoun PharmD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Xiao Ding PhD; Mark Levenson PhD; Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 

Adrian Hernandez MD; Division of Cardiology, Duke University School of Medicine, Durham, NC 

Lingling Li PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Carolyn McCloskey MD, MPH; Eileen Wu PharmD; Gwen Zornberg MD, ScD, MS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Azadeh Shoaibi MS, MHS; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Mary Ross Southworth PharmD; Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD