Selected Medications and Death, with Linkage of Mini-Sentinel Distributed Database with NDI+

Project Title Selected Medications and Death, with Linkage of Mini-Sentinel Distributed Database with NDI+
Date Posted
Tuesday, March 6, 2018
Project ID
to09y05_mpr_wp17_v01, to09y05_mpr_wp22_v01
Status
Discontinued
Deliverables
Description

This project was intended to develop consistent processes for ascertainment of death status and cause of death across all Mini-Sentinel Data Partners by linking potentially relevant cases in the Mini-Sentinel Distributed Database (MSDD) to the National Death Index+ (NDI+), a centralized database of death record information on file in state vital statistics offices. The project was also intended to develop protocol-based assessments of the relationship between exposure to certain medical products of interest and sudden cardiac death (SCD). The medical products of interest included antidepressants and antibiotics, as well as antiarrhythmics as a known positive control group and no specific medications (a general population cohort) as an expected negative control group. FDA decided to discontinue the project in August 2016.

Prior to discontinuation, the workgroup ran preliminary queries to produce sample size estimates. Three separate modular program-based one-time assessments of users of antidepressants, antibiotics, or antiarrhythmics were run against the Mini-Sentinel Distributed Database (MSDD). 

Report 1: Report 1 contains results for antidepressants for the time period January 1, 2000 to March 31, 2013. Antidepressants of interest include: amitriptyline, amoxapine, citalopram, clomipramine, desipramine, desvenlafaxine, doxepin, duloxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, maprotiline, mirtazapine, nefazodone, nortriptyline, paroxetine, protriptyline, sertraline, trazodone, trimipramine, venlafaxine, vilazodone, and vortioxetine. The package was distributed to 18 Data Partners on February 26, 2014.

Report 2: Report 2 contains results for antibiotics for the time period January 1, 2000 to March 31, 2013. Antibiotics of interest include: amoxicillin, amoxicillin with clavulanate, azithromycin, cephalexin, ciprofloxacin, clarithromycin, clindamycin, erythromycin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, penicillin V, telithromycin, and trimethoprim and/or tulfamethoxazole. The package was distributed to 18 Data Partners on February 26, 2014.

Report 3: Report 3 contains results for antiarrhythmics for the time period January 1, 2000 to December 31, 2012. antiarrhythmics of interest include:  amiodarone, dronedarone, dofetilide, flecainide, propafenone, and sotalol. The package was distributed to 18 Data Partners on February 7, 2014.

Medical Product
amiodarone
amitriptyline
amoxapine
amoxicillin
amoxicillin with clavulanate
azithromycin
cephalexin
ciprofloxacin
citalopram
clarithromycin
clindamycin
clomipramine
desipramine
desvenlafaxine
dofetilide
doxepin
dronedarone
duloxetine
erythromycin
escitalopram
flecainide
fluoxetine
fluvoxamine
gemifloxacin
imipramine
levofloxacin
levomilnacipran
maprotiline
mirtazapine
moxifloxacin
nefazodone
norfloxacin
nortriptyline
ofloxacin
paroxetine
penicillin V
propafenone
protriptyline
sertraline
sotalol
sulfamethoxazole/trimethoprim
telithromycin
trazodone
trimipramine
venlafaxine
vilazodone
vortioxetine
Health Outcome
sudden cardiac death
Population / Cohort
All individuals
Time Period
January 1, 2000 - March 31, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Workgroup Leader(s)

Denise Boudreau PhD; Kaiser Permanente Washington Health Research Institute, Seattle, WA

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

Marsha Reichman PhD; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Steven Bird PharmD, PhD, MS; Victor Crentsil MD, MHS; Eric Frimpong PhD, MA; Margie Goulding PhD; David Graham MD, MPH; Terry Harrison PharmD; Monika Houstoun PharmD; Stephine Keeton PhD; Susan Lu PhD, MS; Katrina Mott MS; Rita P. Ouellet-Hellstrom; Simone Pinheiro ScD, MSc; Mary Ross Southworth PharmD; Anne Tobenkin PharmD; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Robert Rosofsky MA; Health Information Systems Consulting, Milton, MA

Sascha Dublin MD, PhD; Monica Fujii MPH; Kristina Hansen BA; Jennifer Nelson PhD; Robert D Wellman MS; Kaiser Permanente Washington Health Research Institute, Seattle, WA

Susan Andrade ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Health, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA

Todd Lee PharmD, PhD; University of Illinois at Chicago, Chicago, IL

Rajat Deo MD, MTR; Sean Hennessy PharmD, PhD; Charles E. Leonard PharmD, MSCE; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

James Floyd MD, MS; Bruce Psaty MD, PhD; David Siscovick; University of Washington, Seattle, WA

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