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

JAMA Intern Med. 2019 Sep 3;179(11):1-3. doi: 10.1001/jamainternmed.2019.3066. Online ahead of print.

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.