| 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 |
