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Safety Assessment of Niacin in the U.S. Food and Drug Administration's Mini-Sentinel System

Basic Details
Date
Monday, November 6, 2017
Type
Publication
Medical Product
extended-release (ER) niacin
fenofibrate
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
Description

The authors of this report compared rates of major gastrointestinal bleeding and intracranial hemorrhage among initiators of extended-release niacin and initiators of fenofibrate.

Materials

Pharmacoepidemiology & Drug Safety 2017;1-8. DOI:10.1002/pds.4343

Information
Time Period
January 1, 2007 - August 31, 2013
Data Source(s)
Mini-Sentinel Distributed Database (MSDD)
Related Assessment(s)
Niacin and Niacin Combination Products, Fenofibrates, and Omega-3 Products
Concomitant Use of Niacin and Statins and Concomitant Use of Fenofibrates and Statins
Niacin and Fenofibrate Use and Outcomes with Propensity Score Matching
Author(s)

Joshua J. Gagne PharmD, ScD, Monika Houstoun PharmD, Marsha E. Reichman PhD, Christian Hampp PhD, James H. Marshall MPH, Sengwee Toh ScD

Corresponding Author

J. J. Gagne, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA 02120, USA. Email: jgagne@bwh.harvard.edu