美FDA建议在白三烯受体拮抗剂的药物标签上应提及其对情绪会产生影响

ST LOUIS (MD Consult) - On June 12, 2009, the US Food and Drug Administration (FDA) issued an update after completing its safety review of the class of asthma drugs known as leukotriene modifiers. The drugs mentioned in the FDA communication include montelukast (marketed as Singulair), zafirlukast (marketed as Accolate), and zileuton (marketed as Zyflo and Zyflo CR). Neuropsychiatric events have been reported in some patients who have taken these medications, and the FDA is now requesting that manufacturers include a precaution in the drug prescribing information.

The post-market reports from patients receiving these leukotrienes include cases of neuropsychiatric events. Some of these reports include clinical details consistent with a drug-induced effect. The neuropsychiatric events that have been reported include agitation, aggression, anxiousness, tremor, hallucinations, depression, dream abnormalities, insomnia, irritability, and restlessness, as well as suicidal thinking and behavior (including suicide). In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to specifically gather information on neuropsychiatric events.

圣路易斯(MD Consult)——2009年6月12日，美国食品药品管理局(FDA)在完成对一类称为白三烯调节剂的哮喘药物的安全审查后发布一项更新通告。该FDA通告中提到的药品包括孟鲁司特(montelukast，商品名：Singulair )、扎鲁司特(zafirlukast，商品名：安可来、Accolate)和齐留通(zileuton ，商品名：Zyflo、Zyflo CR)。部分患者服用上述药品后发生不良神经精神事件，因此FDA现要求制药商在此类药物处方信息中加入相关的注意事项。

服用此类白三烯药物的患者在后市场报告中提到了包括神经精神事件。其中一些报告包括与药物诱导效应相一致的临床细节。报告的神经精神事件包括激越、攻击、焦虑、震颤、幻觉、抑郁、梦境异常、失眠、烦躁、不安以及自杀想法和行为(包括自杀)。在制药商提供的临床试验数据中神经精神事件并不多见。然而，现有数据尚不充分，因为设计的试验并不是以特定地收集神经精神事件为目的。