Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

Noam Tau; Tzippy Shochat; Anat Gafter-Gvili; Ariadna Tibau; Eitan Amir; Daniel Shepshelovich

doi:10.1001/jamainternmed.2019.3066

Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

JAMA Intern Med. 2019 Nov 1;179(11):1590-1592. doi: 10.1001/jamainternmed.2019.3066.

Authors

Noam Tau^{1

2}, Tzippy Shochat³, Anat Gafter-Gvili^{2

4}, Ariadna Tibau⁵, Eitan Amir⁶, Daniel Shepshelovich^{2

4}

Affiliations

¹ Department of Diagnostic Imaging, Sheba Medical Center, Ramat Gan, Israel.
² Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel.
³ Statistics Consulting Unit, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
⁴ Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel.
⁵ Oncology Department, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, and Universitat Autònoma de Barcelona, Barcelona, Spain.
⁶ Princess Margaret Cancer Centre, Division of Medical Oncology, University of Toronto, Toronto, Ontario, Canada.

Abstract

This study describes sources of initial safety signals that that preceded US Food and Drug Administration (FDA) drug safety communications and examines their associations with drug characteristics and subsequent label changes.