Pariente Antoine, Gregoire Fleur, Fourrier-Reglat Annie, Haramburu Françoise, Moore Nicholas
Department of Pharmacology, Universite Victor Segalen, Bordeaux, France.
Drug Saf. 2007;30(10):891-8. doi: 10.2165/00002018-200730100-00007.
Disproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias).
To explore the consequences of safety alerts on reporting disproportionality.
Within the French national pharmacovigilance database, disproportionality of reporting was tested, using the reporting odds ratio (ROR) and its 95% confidence interval, before and after four safety alerts: valvulopathies with pergolide; tuberculosis with infliximab; strokes with atypical antipsychotics; and rhabdomyolysis with HMG-CoA reductase inhibitors (statins) [after cerivastatin withdrawal].
No cases of valvulopathy were reported in association with pergolide before the safety alert and 63 cases were reported after the alert, (ROR 9400; 95% CI 4300, 20 000), of which five had occurred before the alert. Twenty-five reports mentioned rhabdomyolysis associated with statins (not including cerivastatin) before the safety alert (ROR 5.8; 95% CI 3.8, 9.0), and 63 did so after the alert (ROR 9.4; 95% CI 7.0, 13.0). Approximately 280 cases involving cerivastatin were reported after its withdrawal. There were two reports of tuberculosis associated with infliximab before the alert (ROR 1500; 95% CI 130, 18 000) and seven after the alert (ROR 430; 95% CI 110, 1700). There was one report of a stroke in association with atypical antipsychotic treatment before the safety alert (ROR 0.10; 95% CI 0.01, 0.63) and 16 after the alert (ROR 1.10; 95% CI 0.70, 1.90). After excluding events involving treatment with anticoagulant agents, the RORs for stroke in association with atypical antipsychotic treatment were 0.14 (95% CI 0.02, 1.00) before the alert and 2.0 (95% CI 1.2, 3.4) after the alert.
Disproportionality in spontaneous reporting databases increases after a safety alert because of increased reporting of the event of interest, including reports of such events that occurred before the alert. This may overflow to increased reporting of the event in association with other drugs.
自发报告的不成比例分析越来越多地被使用，但它可能受到安全警报（知名度偏差）的未知影响。
探讨安全警报对报告不成比例的影响。
在法国国家药物警戒数据库中，在四项安全警报前后，使用报告比值比（ROR）及其95%置信区间测试报告的不成比例性：培高利特所致瓣膜病；英夫利昔单抗所致结核病；非典型抗精神病药所致中风；以及HMG-CoA还原酶抑制剂（他汀类药物）所致横纹肌溶解症[西立伐他汀撤市后]。
在安全警报前，未报告培高利特相关的瓣膜病病例，警报后报告了63例（ROR 9400；95%CI 4300，20000），其中5例在警报前已发生。在安全警报前，有25份报告提及他汀类药物（不包括西立伐他汀）相关的横纹肌溶解症（ROR 5.8；95%CI 3.8，9.0），警报后有63份报告提及（ROR 9.4；95%CI 7.0，13.0）。西立伐他汀撤市后，报告了约280例涉及其的病例。警报前有两份英夫利昔单抗相关的结核病报告（ROR 1500；95%CI 130，18000），警报后有七份（ROR 430；95%CI 110，1700）。安全警报前有一份非典型抗精神病药治疗相关的中风报告（ROR 0.10；95%CI 0.01，0.63），警报后有16份（ROR 1.10；95%CI 0.70，1.90）。排除涉及抗凝剂治疗的事件后，非典型抗精神病药治疗相关中风的ROR在警报前为0.14（95%CI 0.02，1.00），警报后为2.0（95%CI 1.2，3.4）。
由于感兴趣事件的报告增加，包括警报前发生的此类事件的报告，安全警报后自发报告数据库中的不成比例性增加。这可能会导致与其他药物相关的该事件报告增加。
