Institute for Safe Medication Practices, Alexandria, Virginia, United States of America.
PLoS One. 2010 Dec 15;5(12):e15337. doi: 10.1371/journal.pone.0015337.
Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01).
We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.
Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.
针对他人的暴力行为是一种鲜少研究的药物不良事件，同时也是一种非典型的药物不良事件，因为其伤害风险延伸至他人。
确定药物不良事件报告中描述针对他人的想法或行为的首要嫌疑药物，并评估其关联性的强度。
从食品和药物管理局（FDA）不良事件报告系统（AERS）数据中，我们提取了自 2004 年至 2009 年 9 月收到的，涉及 200 例或更多例严重不良事件报告的所有药物。我们识别出任何表明杀人、杀人意念、身体攻击、身体虐待或与暴力相关的症状的病例报告。
报告的比例失调定义为：a）5 例或更多例暴力病例报告；b）至少是根据该药物的总体报告数量计算的预期报告数量的两倍；c）χ2 统计表明，这些暴力病例不太可能是偶然发生的（p<0.01）。
我们确定了 31 种药物中 1527 例比例失调的暴力病例。首要嫌疑药物包括伐伦克林（一种戒烟辅助药物）、11 种抗抑郁药、6 种镇静/催眠药和 3 种治疗注意力缺陷多动障碍的药物。抗精神病药物的关联性证据较弱且混杂，除了 1 种抗惊厥/情绪稳定剂外，其他药物均无关联性证据。对于所有可评估药物中的 435/484（84.7%），报告的暴力病例只有 2 例或更少，这表明这些药物与这种不良事件的关联性不太可能。
针对他人的暴力行为是一种真实而严重的药物不良事件，与相对较少的药物有关。增加多巴胺可利用度的伐伦克林和具有血清素作用的抗抑郁药是最强烈和一致的嫌疑药物。需要进行前瞻性研究来系统地评估这种副作用，以确定其发生率、确认药物之间的差异，并确定其他共同特征。
