Healthy Skepticism Library item: 4743

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

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 Jan; 117:(1):34-9
http://linkinghub.elsevier.com/retrieve/pii/S0091-6749(05)02325-0

Abstract:

A prominently displayed boxed warning, the so-called “black box,” is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these “black box” warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted.

Keywords:
Drug Labeling* Humans Pharmaceutical Preparations/adverse effects* Product Surveillance, Postmarketing Risk Management Safety United States United States Food and Drug Administration*