Ontology highlight
ABSTRACT:
SUBMITTER: Solotke MT
PROVIDER: S-EPMC6013049 | biostudies-literature | 2018 Feb
REPOSITORIES: biostudies-literature
Solotke Michael T MT Dhruva Sanket S SS Downing Nicholas S NS Shah Nilay D ND Ross Joseph S JS
Expert opinion on drug safety 20171217 2
<h4>Background</h4>The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval.<h4>Methods</h4>We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's ...[more]