The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as “off-label” and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making.

食品和药物管理局的任务是评估药物的功效和安全性。尽管有一个严格的评估程序，但在临床试验期间以及药物上市后进行的观察和研究中可能会出现安全证据，这可能需要加黑框警告。黑框警告是美国食品和药物管理局可以对批准的药物发出的最严重的警告。它通常被称为黑框警告，因为它在包装说明书中用一个厚黑框勾勒出来，以引起处方者和患者的注意。目前有超过 400 种药物带有黑框警告，解决与特定药物相关的主要风险的信息可能会适当或不适当地影响患者和临床医生的决策。医疗保健专业人员必须使用最佳证据和临床判断来决定是否开出带有这些警告的药物。以最初许可的剂量或适应症使用经批准的药物被称为“标签外”，这是合法的、司空见惯的，并且可能是基于证据的。所有药物都可能使患者受到伤害，因此处方者有义务讨论有关益处和危害的最佳可用证据，以便患者可以参与共同决策。