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

Project Title Drugs that Act on the Renin-Angiotensin-Aldosterone System (Angiotensin Converting Enzyme Inhibitors, Angiotensin Receptor Blockers, Aliskiren) and Angioedema
Date Posted
Friday, October 19, 2012
Status
Complete
Deliverables
Related Links
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.

Medical Product
aliskiren
angiotensin II receptor blocker (ARB)
angiotensin-converting enzyme (ACE) inhibitor
Health Outcome
angioedema
Population / Cohort
All individuals 18 years of age or older
Time Period
2001 - 2010
Assessment Type
Safety Analyses
Study Type
Protocol/Surveillance Plan
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

 

Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER