Abstract
The US Food and Drug Administration (FDA) is broadly charged with ensuring food, drug, device, and cosmetic safety for products marketed and sold in the United States. This chapter describes the FDA’s role in anesthesia practice by way of a particular type of practice advisory called a boxed warning or “black box” warning. There are several drugs in anesthetic practice that have these warnings, and clinicians should be aware of the reasons underlying the existence of boxed warnings for these drugs.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Food and Drug Administration. FDA Fundamentals. 2013. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm. Accessed 27 Jul 2013.
Food and Drug Administration. Research tools on FDA history. 2013. http://www.fda.gov/AboutFDA/WhatWeDo/History/ResearchTools/default.htm. Accessed 25 Jul 2013.
Food and Drug Administration. Drug safety communications. 2013. http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm. Accessed 25 Jul 2013.
Cheng CM, Guglielmo BJ, Judy M, Auerbach AD. Coverage of FDA medication boxed warnings in commonly used drug information resources. Arch Intern Med. 2010;170(9):831–3.
Marks NS, Weiss K. Boxed warnings and other FDA communication tools. Am Fam Physician. 2010;81(3):259–260.
Food and Drug Administration. FDA approved drug products. 2013. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed 27 Jul 2013.
Matlock A, Allan N, Wills B, Kang C, Leikin JB. A continuing black hole? The FDA boxed warning: an appeal to improve its clinical utility. Clin Toxicol. 2011;49(6):443–7.
Gan TJ. “Black box” warning on droperidol: a report of the FDA convened expert panel [1]. Anesth Analg. 2004;98(6):1809.
Food and Drug Administration. MedWatch: the FDA safety information and adverse event reporting program. 2013. http://www.fda.gov/Safety/MedWatch/default.htm. Accessed 27 Jul 2013.
O’Connor NR. FDA boxed warnings: how to prescribe drugs safely. Am Fam Physician. 2010;81(3):298–303.
Libby AM, Orton HD, Valuck RJ. Persisting decline in depression treatment after FDA warnings. Arch Gen Psychiatry. 2009;66(6):633–9.
Ehrenpreis ED, Deepak P, Sifuentes H, Devi R, Du H, Leikin JB. The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits. Am J Gastroenterol. 2013;108(6):866–72.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media New York
About this chapter
Cite this chapter
Lane-Fall, M. (2015). Black Box FDA Warnings and Legal Implications. In: Kaye, A., Kaye, A., Urman, R. (eds) Essentials of Pharmacology for Anesthesia, Pain Medicine, and Critical Care. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8948-1_45
Download citation
DOI: https://doi.org/10.1007/978-1-4614-8948-1_45
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-8947-4
Online ISBN: 978-1-4614-8948-1
eBook Packages: MedicineMedicine (R0)