Boxed warning inconsistencies between drug information resources and the prescribing information

American Journal of Health-System Pharmacy

Volumn 68, Issue 17, 2011, Pages 1626-1631

  Cheng, Christine M ^a   Fu, Carrie ^b   Guglielmo, B Joseph ^a   Auerbach, Andrew D ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UCSF ^*

Author keywords

Drug information; Food and Drug Administration (U.S.); Industry, pharmaceutical; Labeling; Regulations; Standards; Toxicity

Indexed keywords

ADALIMUMAB; AMBRISENTAN; BEVACIZUMAB; CANDESARTAN HEXETIL; DALTEPARIN; DOCETAXEL; FENTANYL CITRATE; FORMOTEROL FUMARATE; IOPROMIDE; LEVOFLOXACIN; METOCLOPRAMIDE; PANITUMUMAB; PRASUGREL; RASBURICASE; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; RITONAVIR; ROSIGLITAZONE; VARENICLINE;

ARTICLE; BLACKBOXRX; BOXED WARNING; COMPARATIVE STUDY; DATA BASE; DRUG CONTRAINDICATION; DRUG INFORMATION; DRUG LABELING; DRUG MANUFACTURE; DRUGDEX; EPOCRATES; FACTS AND COMPARISONS; FOOD AND DRUG ADMINISTRATION; HUMAN; LEXI DRUGS; PDR NET; PHARMACIST; PRESCRIBING INFORMATION; PRESCRIPTION; PRIORITY JOURNAL; RELIABILITY;

EID: 80052733328     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp110025     Document Type: Article

References (22)

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 Draft guidance.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/GuidanceComplianceRegulatory Information/Guidances/ ucm075096.pdf (accessed 2010 Nov 15).
3. O'Connor NR. FDA boxed warnings: how to prescribe drugs safely. Am Fam Physician. 2010; 81:298-303.
4. Ceilley R, Eisenthal A. The unintended effects of a boxed warning. J Clin Aesthet Dermatol. 2009; 2(9):33-9.
5. Libby AM, Orton HD, Valuck RJ. Persisting decline in depression treatment after FDA warnings. Arch Gen Psychiatry. 2009; 66:633-9.
6. Lasser KE, Allen PD, Woolhandler SJ et al. Timing of new black box warnings and withdrawals for prescription medicines. JAMA. 2002; 287:2215-20. (Pubitemid 34441937)
7. Lal R, Kremzer M. Introduction to the new prescription drug labeling by the Food and Drug Administration. Am J Health-Syst Pharm. 2007; 64:2488-94. (Pubitemid 350209840)
8. Cheng CM, Guglielmo BJ, Maselli J et al. Coverage of FDA medication boxed warnings in commonly used drug information resources. Arch Intern Med. 2010; 170:831-3.
9. Thompson CA. Hospital inspectors eye black-box warnings. Am J Health-Syst Pharm. 2008; 65:890-4. News. (Pubitemid 351680034)
10. Rosenberg JM, Koumis T, Nathan JP et al. Current status of pharmacist-operated drug information centers in the United States. Am J Health-Syst Pharm. 2004; 61:2023-32. (Pubitemid 39481332)
11. Kupferberg N, Jones HL. Evaluation of five full-text drug databases by pharmacy students, faculty and librarians: do the groups agree? J Med Libr Assoc. 2004; 92:66-71. (Pubitemid 38298594)
12. Institute for Safe Medication Practices. Medication safety tools and resources: black box warnings. www.ismp.org/Tools/default.asp (accessed 2010 Dec 10).
13. Food and Drug Administration. Center for Drug Evaluation and Research Drugs@FDA database. www.accessdata. fda.gov/scripts/cder/drugsatfda (accessed 2010 Nov 10).
14. National Library of Medicine. DailyMed Current Medication Information page. http://dailymed.nlm.nih.gov/dailymed (accessed 2010 Nov 16).
15. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977; 33:159-74. (Pubitemid 8054849)
16. Clauson KA, Marsh WA. Clinical decision support tools: analysis of online drug information databases. BMC Med Inform Decis Mak. 2007; 7:7.
17. Polen HH, Zapantis A, Clauson KA et al. Ability of online drug databases to assist in clinical decision-making with infectious disease therapies. BMC Infect Dis. 2008; 8:153.
18. MedWatch. Safety alerts for human medical products webpage. www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/default.htm (accessed 2010 Dec 10).
19. MedWatch. Drug safety labeling changes webpage. www.fda.gov/Safety/ MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/default. htm (accessed 2010 Dec 10).
20. Lasser KE, Seger DL, Yu T et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med. 2006; 166:338-44.
21. Roden DM, Shuldiner AR. Responding to the clopidogrel warning by the US Food and Drug Administration: real life is complicated. Circulation. 2010; 122:445-8.
22. Lineberry TW, Bostwick JM, Beebe TJ et al. Impact of the FDA black box warning on physician antidepressant prescribing and practice patterns: opening Pandora's suicide box. Mayo Clin Proc. 2007; 82:518-20. (Pubitemid 46543478)