@article{f3715b4c72a94be6836edf1795aaa40a,
title = "New and incremental FDA black box warnings from 2008 to 2015",
abstract = "Background: The boxed warning (also known as {\textquoteleft}black box warning [BBW]{\textquoteright}) 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. Methods: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA{\textquoteright}s MedWatch and Drug Safety Communications websites. We used each drug{\textquoteright}s prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. Results: There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. Conclusions: New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.",
keywords = "Black box warning, boxed warning, drug labeling, drug safety, food and drug administration",
author = "Solotke, {Michael T.} and Dhruva, {Sanket S.} and Downing, {Nicholas S.} and Shah, {Nilay D.} and Ross, {Joseph S.}",
note = "Funding Information: This paper was funded by NIH training grant award T35DK104689. Funding Information: Mr. Solotke received a student research grant provided by the Yale School of Medicine Office of Student Research under NIH training grant award T35DK104689 (National Institute of Diabetes and Digestive and Kidney Diseases). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors assume full responsibility for the accuracy and completeness of the ideas presented. Over the past 36 months, Dr. Ross received support from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program. Dr. Ross also received support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices, from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers for Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, from the Agency for Healthcare Research and Quality to examine community predictors of healthcare quality, and from the Laura and John Arnold Foundation, which established the Collaboration for Research Integrity and Transparency (CRIT) at Yale University. Dr. Dhruva is funded by the Department of Veterans Affairs. Over the past 36 months, Dr. Shah received support from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program. In addition, Dr. Shah received support through the Mayo Clinic from the Centers for Medicare and Medicaid Services (CMS) and from the Agency for Healthcare Research and Quality. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclosed. Publisher Copyright: {\textcopyright} 2017 Informa UK Limited, trading as Taylor & Francis Group.",
year = "2018",
month = feb,
day = "1",
doi = "10.1080/14740338.2018.1415323",
language = "English (US)",
volume = "17",
pages = "117--123",
journal = "Expert Opinion on Drug Safety",
issn = "1474-0338",
publisher = "Informa Healthcare",
number = "2",
}