Barry W S, Meinzinger M M, Howse C R
Am J Med. 1984 Jul 13;77(1A):35-9. doi: 10.1016/s0002-9343(84)80016-9.
A voluntary reporting system has been established by the manufacturer of ibuprofen (Motrin) to detect, collect, and document medical events related to its use that were not or could not be obtained by controlled clinical trials, such as data on overdose and fetal exposure. Of over 100 million prescriptions for ibuprofen written in the United States in the last nine years, only 67 cases of overdose or accidental ingestion have been reported, 36 percent of which occurred in children less than three years old. There have been only three reports of fatalities, all in adults. Also during this nine-year period, 50 reports of exposure in utero have been received. However, no abnormalities have been seen in any patient followed up prospectively from exposure through delivery.
布洛芬（美林）制造商已建立了一个自愿报告系统，以检测、收集和记录与使用该药相关的医疗事件，这些事件无法通过对照临床试验获得，例如过量用药和胎儿接触的数据。在过去九年里，美国开出了超过1亿份布洛芬处方，仅报告了67例过量用药或意外摄入病例，其中36%发生在三岁以下儿童身上。仅有三例死亡报告，均为成人。同样在这九年期间，收到了50例子宫内接触的报告。然而，从接触到分娩进行前瞻性随访的任何患者中均未发现异常情况。
