Jazz Pharmaceuticals, Inc. Palo Alto, CA 94304, USA.
J Clin Sleep Med. 2009 Aug 15;5(4):365-71.
This study reviewed the cumulative postmarketing and clinical safety experience with sodium oxybate (Xyrem), a treatment approved for cataplexy and excessive daytime sleepiness in narcolepsy. Study objectives were to investigate the occurrence of abuse/misuse of sodium oxybate since first market introduction in 2002, classify cases using DSM-IV criteria for substance abuse and dependence, and describe specific characteristics of these cases.
We retrospectively reviewed postmarketing spontaneous adverse event (AE) reports from 15 countries for all cases containing reporting terminology related to abuse/misuse to determine its occurrence. All death cases independent of causality were reviewed to identify associated risk factors.
Approximately 26,000 patients worldwide received sodium oxybate from first market introduction in 2002 through March 2008. Of those 26,000 patients, 0.2% reported > or = 1 of the events studied. These included 10 cases (0.039%) meeting DSM-IV abuse criteria, 4 cases (0.016%) meeting DSM-IV dependence criteria, 8 cases (0.031%, including 3 of the previous 4) with withdrawal symptoms reported after discontinuation of sodium oxybate, 2 confirmed cases (0.008%) of sodium oxybate-facilitated sexual assault, 8 cases (0.031%) of overdose with suicidal intent, 21 deaths (0.08%) in patients receiving sodium oxybate treatment with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. During this period, approximately 600,000 bottles of sodium oxybate were distributed, and 5 incidents (0.0009%) of diversion were reported.
Cumulative postmarketing and clinical experience indicates a very low risk of abuse/misuse of sodium oxybate.
本研究回顾了自 2002 年首次上市以来，用于治疗猝倒症和嗜睡症的药物羟丁酸钠（Xyrem）的上市后和临床安全性累积经验。研究目的是调查自 2002 年首次上市以来羟丁酸钠滥用/误用的发生情况，根据 DSM-IV 物质滥用和依赖标准对病例进行分类，并描述这些病例的具体特征。
我们回顾了来自 15 个国家的上市后自发不良事件（AE）报告，对所有包含与滥用/误用相关报告术语的病例进行了回顾，以确定其发生情况。对所有与因果关系无关的死亡病例进行了审查，以确定相关的危险因素。
自 2002 年首次上市至 2008 年 3 月，全球约有 26000 名患者接受了羟丁酸钠治疗。在这 26000 名患者中，有 0.2%报告了≥1项研究事件。这些事件包括 10 例（0.039%）符合 DSM-IV 滥用标准的病例，4 例（0.016%）符合 DSM-IV 依赖标准的病例，8 例（0.031%，包括之前的 4 例中的 3 例）在停用羟丁酸钠后出现戒断症状的病例，2 例（0.008%）确认为羟丁酸钠辅助性性侵犯的病例，8 例（0.031%）有自杀意图的过量用药病例，21 例（0.08%）接受羟丁酸钠治疗的患者死亡，已知 1 例与羟丁酸钠有关，3 例（0.01%）涉及服用羟丁酸钠的司机的交通事故病例。在此期间，约有 600000 瓶羟丁酸钠被分发，报告了 5 起（0.0009%）转移事件。
上市后和临床累积经验表明，羟丁酸钠滥用/误用的风险非常低。
