Department of Emergency Medicine, Division of Medical Toxicology, University of California San Diego, San Diego, CA 92103, USA.
Ann Pharmacother. 2009 Dec;43(12):1986-91. doi: 10.1345/aph.1M454. Epub 2009 Nov 24.
Varenicline was approved by the Food and Drug Administration (FDA) as a prescription smoking cessation aid in May 2006. Varenicline is both a partial nicotine agonist and an antagonist. Recent reports by the Institute of Safe Medication Practices identified safety problems associated with varenicline use, and the FDA recently issued a boxed warning. These safety concerns regarding varenicline use prompted this study.
To characterize varenicline-exposed patients as reported to a poison control system.
We performed a retrospective search of the California Poison Control System electronic database from August 2006 through August 2008, using the term varenicline or Chantix. Cases matching these results were reviewed. All ages were included. Excluded were patients with coingestants and unknown outcomes. Clinical parameters and medical outcomes were extracted from the database.
Thirty-six cases met inclusion criteria and 17 cases were excluded, Ten cases involved nonpediatric patients; 9 cases involved patients less than 6 years old, which were defined as pediatric patients. The median duration of poison center follow-up for pediatric patients was 253 minutes; median duration of follow-up for nonpediatric patients with unintentional exposures was 28.5 minutes. The majority of exposures were unintentional and included all the pediatric patients and 6 nonpediatric patients who had unintentional medication errors. Gastrointestinal and neuropsychiatric adverse events were most frequently reported. The majority of these patients were managed at home. Among those evaluated at a healthcare facility, only 1 pediatric patient was admitted. Of the remaining patients, 1 nonpediatric patient reported a deliberate exposure and 3 nonpediatric patients experienced adverse effects at therapeutic doses. Median duration of follow-up for these patients was 308 minutes.
Patients exposed to varenicline in our study had favorable outcomes. Gastrointestinal and neuropsychiatric effects were the most commonly reported adverse events. A dose-response relationship could not be determined and triage criteria to a healthcare facility remain undetermined.
伐伦克林于 2006 年 5 月获得美国食品和药物管理局（FDA）批准，作为处方戒烟辅助药物。伐伦克林既是部分尼古丁激动剂，也是拮抗剂。最近，安全用药实践研究所报告了与伐伦克林使用相关的安全问题，FDA 最近发布了一则黑框警告。这些关于伐伦克林使用的安全问题促使我们进行了这项研究。
描述向中毒控制系统报告的伐伦克林暴露患者。
我们对 2006 年 8 月至 2008 年 8 月期间加州中毒控制系统电子数据库进行了回顾性检索，使用术语伐伦克林或畅沛。对符合这些结果的病例进行了审查。所有年龄段的患者均被纳入。排除了共同摄入者和未知结局的患者。从数据库中提取了临床参数和医疗结局。
符合纳入标准的有 36 例，排除了 17 例。10 例涉及非儿科患者；9 例涉及年龄小于 6 岁的患者，这些患者被定义为儿科患者。儿科患者中毒控制中心随访的中位数时间为 253 分钟；非儿科患者因非故意药物误用的中位数随访时间为 28.5 分钟。大多数暴露是无意的，包括所有儿科患者和 6 名因非故意药物错误而发生暴露的非儿科患者。胃肠道和神经精神不良事件是最常报告的不良事件。大多数患者在家中接受治疗。在那些到医疗机构就诊的患者中，只有 1 名儿科患者被收治入院。其余患者中，1 名非儿科患者报告了故意暴露，3 名非儿科患者在治疗剂量下出现了不良反应。这些患者的中位数随访时间为 308 分钟。
在我们的研究中，接触伐伦克林的患者结局良好。胃肠道和神经精神效应是最常报告的不良事件。无法确定剂量-反应关系，也无法确定分诊到医疗机构的标准。
