University of Florida College of Pharmacy, Department of Pharmaceutical Outcomes and Policy, 1225 Center Drive, HPNP 3334, Gainesville, FL 32611, USA.
Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):302-5. doi: 10.1002/pds.3395. Epub 2013 Jan 2.
This study characterizes drug safety-related label changes by evidence source contribution, time from drug approval to label change, initiator (FDA or sponsor), and drug class.
A retrospective review of the FDA's internal files was used to obtain regulatory documentation on drugs undergoing a 2010 label change. Contribution of evidence sources were identified and label change initiator and drug class were determined for each drug.
A total of 371 drugs were analyzed. Spontaneous reports contributed to 52% and 55% of label changes when analyzed by unique safety issue and drug, respectively. The median time from approval to 2010 safety-related label change was 11 years. The sponsor was more likely than the FDA to initiate a label change (58% and 42%). Label changes were most common among nervous system drugs (23%), antiinfectives for systemic use (17%), and cardiovascular system drugs (14%).
Drug label changes involve contributions from multiple evidence sources. The findings from this comprehensive review are consistent with previous findings and demonstrate (i) the continued importance of the spontaneous reporting system and complementary evidence sources and (ii) safety-related label changes take place years after postmarket approval, emphasizing the importance of continued drug safety surveillance throughout a product's lifecycle.
本研究通过证据来源贡献、从药物批准到标签变更的时间、发起者（FDA 或赞助商）和药物类别，对与药物安全相关的标签变更进行了特征描述。
本研究采用回顾性审查 FDA 内部档案的方法，获取了 2010 年进行标签变更的药物的监管文件。确定了每种药物的证据来源贡献，并确定了标签变更发起者和药物类别。
共分析了 371 种药物。单独分析安全问题和药物时，自发报告分别占标签变更的 52%和 55%。从批准到 2010 年与安全性相关的标签变更的中位时间为 11 年。与 FDA 相比，赞助商更有可能发起标签变更（分别为 58%和 42%）。标签变更最常见于神经系统药物（23%）、全身抗感染药物（17%）和心血管系统药物（14%）。
药物标签变更涉及多个证据来源的贡献。本全面审查的结果与之前的研究结果一致，表明（i）自发报告系统和补充证据来源仍然具有重要意义，（ii）药物上市批准后多年才会进行与安全性相关的标签变更，强调了在产品生命周期内持续进行药物安全性监测的重要性。
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