Drug Saf. 2013 Nov;36(11):1117-23. doi: 10.1007/s40264-013-0115-x.
The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario.
To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect.
Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years).
In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %).
There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed in the design or interpretation of analyses based on AE reports.
韦伯效应指出，新药上市后的头 2 年，不良事件（AE）报告数量趋于增加，在第二年年底达到峰值，然后下降。然而，自从韦伯效应最初被描述以来，医疗保健专业人员和消费者在安全信息的沟通以及 AE 报告的新政策方面已经有所改进，这促使我们重新评估当前 AE 报告情况下韦伯效应的存在。
确定 2006 年批准的新型分子实体（NME）药物和生物制剂的 AE 报告模式，并研究这些模式中韦伯效应的存在。
使用公开的 FDA 不良事件报告系统数据，从药物批准之日起评估 5 年期间的 AE 报告模式。根据报告日期，基于所有来源的年度报告总数绘制了与时间（年）的关系图。
在 2006 年至 2011 年期间，共提交了 19 种 2006 年批准的 NME 的 91187 份 AE 报告。AE 报告数量最多的是伐伦克林酒石酸盐（N = 47158），最低的是阿尼达非格（N = 161）。阿尼达非格报告的死亡报告比例最高（36%），伐伦克林酒石酸盐报告的比例最低（1.7%）。韦伯经典模式在 2006 年批准的 19 种 NME 中均未观察到。虽然 AE 报告量没有一种单一的主导模式，但我们将药物分为四大类；大多数药物要么报告持续增加（A 类 31.6%），要么呈现 N 型模式，即报告在第 2 年或第 3 年达到初始峰值，然后下降，然后再次开始攀升（B 类 42.1%）。
自韦伯效应首次报道以来，AE 报告发生了许多变化，特别是总体年度报告数量大幅增加。我们的结果表明，在基于 AE 报告的设计或分析中，不应假设出现韦伯型报告模式。
