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JACI Highlights - January 2006
Black Box 101: How FDA evaluates, communicates, and manages drug benefit/risk
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 (FDA) 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 the January 2006 issue of the Journal of Allergy and Clinical Immunology, Murphy and colleagues provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefits and risk. Drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and post-marketing safety surveillance are discussed. In addition, health care providers are encouraged to report drug reactions to the Food and Drug Administration's MedWatch program, a program put in place by the FDA to rapidly disseminate new safety information. New FDA initiatives to improve drug safety processes and methods to better serve the public are also highlighted.
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