black box warning
Introduction
Prominently displayed summaries of serious adverse reactions & potential safety hazards for a drug product in its prescribing information as required by the Food & Drug Administration (FDA). These boxed warnings are the most serious of warnings for a drug. Require informed patient consent prior to prescription.
A box warning is implemented when
- a drug presents a unique risk to benefit concern compared with other drugs in the same class
- when the risk to benefit ratio is high
- adverse reactions can be minimzed by restricted use or stric attention to cautions
These boxed warnings are described in the U.S. Food & Drug Administration, Center for Devices & Radiological Health, Code of Federal Regulations [21CFR 201.57(e)].1-4
Prescribers must provide patients with information on
- treatment risks
- benefits
- warnings as part of the patient's right of informed consent.
Black box warnings may be based on association NOT proof.
Black box warning does not mean 'do not use'.
Follow recommendations. Monitor or rule out problems suggested by black box warning.
A MedGuide may accompany black box warning.
Black box warning are associated with:
- drugs associated with Black box warning [A-L]
- drugs associated with Black box warning [M-Z]
More general terms
References
- ↑ Prescriber's Letter 13(3): 2006 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220332&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Murphy S, Roberts R. Black box 101: how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol 2006;117:34-9.
- ↑ Aaronson DW. The black box warning and allergy drugs. J Allergy Clin Immunol 2006;117:40-4.
- ↑ Prescriber's Letter 14(10): 2007 Dispensing/prescribing against product labeling sample of consent form for prescribers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=231001&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Cheng CM, Shin J, Guglielmo BJ Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012. JAMA Intern Med. Published online August 15, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25127107 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=1897290
Wolfe SM Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological ProductsA Misguided Approach. JAMA Intern Med. Published online August 15, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25127222 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=1897291 - ↑ Drug product information may be found at Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.