Boxed warning inconsistencies between drug information resources and the prescribing information

Author:

Cheng Christine M.1,Fu Carrie2,Guglielmo B. Joseph3,Auerbach Andrew D.1

Affiliation:

1. Department of Clinical Pharmacy, Medication Outcomes Center, University of California, San Francisco (UCSF), San Francisco

2. School of Pharmacy, UCSF, at the time of this study

3. Department of Clinical Pharmacy

Publisher

Oxford University Press (OUP)

Subject

Health Policy,Pharmacology

Reference22 articles.

1. 21 C.F.R.1.21. http://edocket.access.gpo.gov/cfr_2001/aprqtr/pdf/21cfr201.57.pdf (accessed 2010 Nov 16).

2. Food and Drug Administration. Guidance for industry. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. Draft guidance. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf (accessed 2010 Nov 15).

3. FDA boxed warnings: how to prescribe drugs safely;O’Connor;Am Fam Physician.,2010

4. The unintended effects of a boxed warning;Ceilley;J Clin Aesthet Dermatol.,2009

5. Persisting decline in depression treatment after FDA warnings;Libby;Arch Gen Psychiatry.,2009

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