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.