Top

Drug Safety

Published in:

01-10-2019 | Aripiprazole | Research Letter

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System

Authors: Monica A. Muñoz, Gerald J. Dal Pan

Published in: Drug Safety | Issue 10/2019

Excerpt

Dear Editor, …

Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, et al. Effect of lawyer-submitted reports on signals of disproportional reporting in the food and drug administration’s adverse event reporting system. Drug Saf. 2019;42(1):85–93.CrossRefPubMed

US FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 4 Apr 2019.

DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.

Harinstein L, Kalra D, Kortepeter CM, Munoz MA, Wu E, Dal Pan GJ. Evaluation of postmarketing reports from industry-sponsored programs in drug safety surveillance. Drug Saf. 2019;42(5):649–55.CrossRefPubMed

Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P. When more is less: an exploratory study of the precautionary reporting bias and its impact on safety signal detection. Clin Pharmacol Ther. 2018;103(2):296–303.CrossRefPubMed

Title: The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System
Authors: Monica A. Muñoz
Gerald J. Dal Pan
Publication date: 01-10-2019
Publisher: Springer International Publishing
Keywords: Aripiprazole
Paliperidone
Published in: Drug Safety / Issue 10/2019
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-019-00834-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

Please log in to get access to this content

Other articles of this Issue 10/2019

Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350

Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature

Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity

19th ISoP Annual Meeting “New Opportunities for New Generations” Bogotá, Colombia, 26–29 October, 2019