Black box warnings: what do they mean to pharmacists and patients.
The Food and Drug Administration (FDA), which oversees and regulates prescription and over-the-counter medications, issues several types of advisories about medication safety. Pharmacists and other practitioners are responsible for carefully evaluating these communications and assessing the potential risk for their individual patients. Focusing on black box warnings-the most serious type of warning from FDA-this article discusses a strategy for evaluating and implementing FDA's safety warnings to provide optimal patient care.
Caren McHenry
CM
Martin
Laura
L
Borgelt
D017277:Drug Approval; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010595:Pharmacists / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration