“Black box” 101: How the Food and Drug Administration 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 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.

Key words: Food and Drug Administration, adverse drug reactions, MedWatch, “black box” warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development

Abbreviations used: AERS, Adverse Event Reporting System, CDER, Center for Drug Evaluation and Research, CFR, Code of Federal Regulations, DSOB, Drug Safety Oversight Board, FDA, US Food and Drug Administration, IND, Investigational new drug, PDR, Physicians Desk Reference, NDA, New drug application