Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels

Author:

Yeh James S.ORCID,Sarpatwari Ameet,Kesselheim Aaron S.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference31 articles.

1. Ricci JR, Coulen C, Berger JE, Moore MC, McQueen A, Jan SA. Prescriber compliance with black box warnings in older adult patients. Am J Manag Care. 2009;15(11):e103–8.

2. Cheung A, Sacks D, Dewa CS, Pong J, Levitt A. Pediatric prescribing practices and the FDA black-box warning on antidepressants. J Dev Behav Pediatr. 2008;29(3):213–5.

3. Center for Biologics Evaluation and Research. Safety labeling changes—implementation of section 505(o)(4) of the FD&C Act. Rockville: Center for Biologics Evaluation and Research; 2013. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm250783.pdf . Accessed 14 Jan 2016.

4. Marks NS, Weiss K. Boxed warnings and other FDA communication tools. Am Fam Physician. 2010;81(3):259.

5. Cheng CM, Guglielmo BJ, Maselli J, Auerbach AD. Coverage of FDA medication boxed warnings in commonly used drug information resources. Arch Intern Med. 2010;170(9):831–3.

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