Timing of new black box warnings and withdrawals for prescription medications
Timing of new black box warnings and withdrawals for prescription medications
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DOI：
10.1001/jama.287.17.2215
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发表时间：
2002-05-01
影响因子：
120.7
通讯作者：
Bor, DH
中科院分区：
文献类型：
--
作者：
Lasser, KE;Allen, PD;Bor, DH
最近批准的药物可能比已确定的药物更有可能发生未识别的药物不良反应（ADR），目的探讨药品上市后监测发现严重不良反应的频率和时间，为临床合理用药提供参考。美国食品和药物管理局在1975年至1999年间批准的新化学实体，以及1975年至2000年间从市场上撤回的所有药物（有或没有预先的黑盒警告）.主要结果测量新的黑盒警告或停药的频率和时间.结果在1975-1999年总共批准了548个新的化学实体; 56例（10.2%）获得新的黑框警告或被撤回。45种药物（8.2%）获得了1个或多个黑框警告，16种（2.9%）被撤回市场。在Kaplan-Meier分析中，获得新的黑盒警告或在25年内退出市场的估计概率为20%。医生案头参考中的药物标签发生了81项重大变更，包括每种药物增加1个或多个黑框警告或停药。在Kaplan-Meier分析中，这些变化中有一半发生在药物引入后7年内;一半的退出发生在2 years.Conclusions严重的ADR通常出现在食品和药物管理局批准后。新药的安全性只有在上市多年后才能确定。
Context Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.Objective To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.Design and Setting Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning).Main Outcome Measures Frequency of and time to a new black box warning or drug withdrawal.Results A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.Conclusions Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.