“药品未标示用途”是否合法？
Are "off-labels" legal?
作者信息
Price E C
机构信息
Detroit College of Law, Michigan State University, East Lansing, USA.
出版信息
Mich Health Hosp. 1998 Nov-Dec;34(6):20-1.
PMID:10187136
Abstract
A doctor prescribes a beta-blocker to calm a patient's muscle tremors, even though the Food and Drug Administration (FDA) has only approved the drug for use in lowering blood pressure. A physician recommends that a patient wear a nicotine patch as a treatment for colitis. A pediatrician prescribes a drug that has been approved for adult use only. Such "off-label" prescriptions are increasingly common--and legal.
摘要
医生开出β受体阻滞剂来平复患者的肌肉震颤，尽管美国食品药品监督管理局（FDA）仅批准该药物用于降血压。一名内科医生建议患者使用尼古丁贴片来治疗结肠炎。一名儿科医生开出了一种仅被批准用于成人的药物。这种“未按批准标签用药”的处方越来越普遍，而且是合法的。
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