Cough and cold medication adverse events after market withdrawal and labeling revision.
Cough and cold medication adverse events after market withdrawal and labeling revision.
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DOI：
10.1542/peds.2013-2236
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发表时间：
2013-12
期刊：
影响因子：
8
通讯作者：
Budnitz DS
中科院分区：
文献类型：
--
作者：
Hampton LM;Nguyen DB;Edwards JR;Budnitz DS
2007年10月，制造商自愿从美国市场撤回非处方婴儿咳嗽和感冒药（CCMs）。一年后，制造商宣布将修改OTC CCM标签，警告4岁以下儿童不要使用OTC CCM。我们确定在这些干预措施后，CCM药物不良事件（ADEs）的急诊科（ED）就诊人数是否下降。我们使用2004年至2011年国家电子伤害监测系统-合作药物不良事件监测数据来估计每次干预前后CCM ade的急诊科就诊次数。在<2岁的儿童中，CCM ADE的ED就诊从市场退出前的4.1%下降到市场退出后的2.4%（比例差异：-1.7%，95%置信区间[CI]: -2.7%至-0.6%）。在2至3岁的儿童中，CCM ADE的ED就诊从标签修订公告前的9.5%下降到标签修订公告后的6.5%（比例差异：-3.0%,95% CI: -5.4%至-0.6%）。无监督摄入占停药后2岁以下儿童CCM ADE ED就诊的64.3% (95% CI: 51.1%至77.5%)，占标签修订公告后2至3岁儿童就诊的88.8% （95% CI: 83.8%至93.8%）。在自愿退出市场和标签修订后，与所有药物的ADE ED就诊相比，CCM ADE在<2岁和2至3岁儿童中的ED就诊次数有所下降。需要采取干预措施解决无监督摄入问题，以减少CCM ade。
In October 2007, manufacturers voluntarily withdrew over-the-counter (OTC) infant cough and cold medications (CCMs) from the US market. A year later, manufacturers announced OTC CCM labeling would be revised to warn against OTC CCM use by children aged <4 years. We determined whether emergency department (ED) visits for CCM adverse drug events (ADEs) declined after these interventions. We used National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance data from 2004 to 2011 to estimate the number of ED visits for CCM ADEs before and after each intervention. Among children aged <2 years, ED visits for CCM ADEs decreased from 4.1% of all ADE ED visits before the market withdrawal to 2.4% of all ADE visits afterward (difference in proportion: –1.7%, 95% confidence interval [CI]: –2.7% to –0.6%). Among children aged 2 to 3 years, ED visits for CCM ADEs decreased from 9.5% of all ADE ED visits before the labeling revision announcement to 6.5% of all ADE visits afterward (difference in proportion: –3.0%, 95% CI: –5.4% to –0.6%). Unsupervised ingestions accounted for 64.3% (95% CI: 51.1% to 77.5%) of CCM ADE ED visits involving children aged <2 years after the withdrawal and 88.8% (95% CI: 83.8% to 93.8%) of visits involving children aged 2 to 3 years after the labeling revision announcement. After a voluntary market withdrawal and labeling revision, ED visits for CCM ADEs declined among children aged <2 years and 2 to 3 years relative to ADE ED visits for all drugs. Interventions addressing unsupervised ingestions are needed to reduce CCM ADEs.