背景:药物诱导自杀(DIS)是一种严重的药物不良反应(ADR)。尽管临床试验提供了DIS的证据,对罕见的ADR进行了有限的调查,比如自杀。
目的:我们旨在系统审查DIS的病例报告,以提供循证药物信息。
方法:我们搜索了PubMed,以获取截至2021年7月发布的关于DIS的病例报告。不再使用或未经批准的药物引起的病例,物质使用,并排除了自杀意图。使用CASE(病例报告)清单评估每个病例报告的质量。我们提取了人口统计数据,用药史,自杀症状,和症状改善,并使用Naranjo评分评估DIS的因果关系。此外,为了确定未知药物的潜在自杀风险,我们将因果关系评估的结果与批准的药物标签的结果进行了比较.
结果:在83篇文章中,我们确定了152例病例,涉及61种药物。据报道,抗抑郁药是DIS最常见的致病药物,其次是免疫刺激剂。因果关系评估显示61例可能,89例可能的病例,2例与DIS有明确关系。大约85%的可疑药物在批准的标签上注明了自杀性ADR的风险;然而,9种药物的批准标签,包括lumacaftor/ivacaftor,多西环素,氯氮平,右美沙芬,阿达木单抗,英夫利昔单抗,吡罗昔康,紫杉醇,和福莫特罗,没有提供有关这些风险的信息。
结论:我们在药物标签上发现了一些涉及药物的病例报告,这些报告没有自杀风险信息。我们的发现可能为可能导致自杀性ADR的药物提供有价值的见解。
BACKGROUND: Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on rare ADRs, such as suicide.
OBJECTIVE: We aimed to systematically review case reports on DIS to provide evidence-based drug information.
METHODS: We searched PubMed to obtain case reports regarding DIS published until July 2021. Cases resulting from drugs that are no longer used or are nonapproved, substance use, and
suicidal intentions were excluded. The quality of each case report was assessed using the CASE (Case Reports) checklist. We extracted data regarding demographics, medication history, suicide symptoms, and symptom improvement and evaluated the causality of DIS using the Naranjo score. Furthermore, to identify the potential
suicidal risk of the unknown drugs, we compared the results of the causality assessment with those of the approved drug labels.
RESULTS: In 83 articles, we identified 152 cases involving 61 drugs. Antidepressants were reported as the most frequent causative drugs of DIS followed by immunostimulants. The causality assessment revealed 61 cases having possible, 89 cases having probable, and 2 cases having definite relationships with DIS. For approximately 85% of suspected drugs, the risk of
suicidal ADRs was indicated on the approved label; however, the approved labels for 9 drugs, including lumacaftor/ivacaftor, doxycycline, clozapine, dextromethorphan, adalimumab, infliximab, piroxicam, paclitaxel, and formoterol, did not provide information about these risks.
CONCLUSIONS: We found several case reports involving drugs without suicide risk information on the drug label. Our findings might provide valuable insights into drugs that may cause
suicidal ADRs.