Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: An analysis of the Food And Drug Administration Adverse Events Reporting System (FAERS)
Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: An analysis of the Food And Drug Administration Adverse Events Reporting System (FAERS)
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DOI：
10.1016/j.sapharm.2018.06.018
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发表时间：
2019-08-01
影响因子：
3.9
通讯作者：
Hultgren, Kyle E.
中科院分区：
文献类型：
--
作者：
Evoy, Kirk E.;Covvey, Jordan R.;Hultgren, Kyle E.
背景：近年来，关于加巴喷丁类（加巴喷丁和普瑞巴林）滥用的报道有所增加。来自美国食品和药物管理局不良事件报告系统（FAERS）的药物警戒数据为安全信号检测提供了对药物不良事件（ADE）报告的有用检查。目的：利用FAERS数据库分析加巴喷丁/普瑞巴林滥用的性质和程度的流行病学信息。方法：利用2012年10月至2016年12月FAERS数据库SafeRx设计查询。加巴喷丁和普瑞巴林的全因和滥用相关（包括滥用/误用/依赖/过量事件）ADE报告是孤立的，以及有限的人口统计数据。计算比例报告比（PRR）来比较信号检测。结果：FAERS共报告10038例加巴喷丁全因ade，其中576例（5.7%）与滥用相关。对于普瑞巴林，发现571例全因ade，其中58例（10.2%）与滥用有关。与所有原因的ade相比，与虐待有关的事件的患者更年轻，更有可能是男性。普瑞巴林与加巴喷丁滥用相关事件的PRR为1.77。结论：虽然传统上认为加巴喷丁类药物不属于滥用药物，但在分析的时间框架内报告了600多例加巴喷丁类药物滥用，需要进一步研究和监管调查。
Background: Reports of gabapentinoid (gabapentin and pregabalin) misuse have increased in recent years. Pharmacovigilance data from the Food and Drug Administration Adverse Event Reporting System (FAERS) provides a useful examination of adverse drug event (ADE) reporting for safety signal detection.Objective: This study was conducted to analyze epidemiological information on the nature and extent of gabapentin/pregabalin abuse utilizing the FAERS database.Methods: A query was designed utilizing SafeRx, an indexed, searchable database of FAERS data from October 2012-December 2016. All-cause and abuse-related (including abuse/misuse/dependence/overdose events) ADE reports for gabapentin and pregabalin were isolated, as well as limited demographic data. The proportional reporting ratio (PRR) was calculated to compare signal detection.Results: A total of 10,038 all-cause ADEs were reported to FAERS for gabapentin, including 576 (5.7%) abuse-related events. For pregabalin, 571 all-cause ADEs were identified, including 58 (10.2%) related to abuse. Compared to all-cause ADEs, those involved in abuse-related events were younger and more likely to be male. The PRR of pregabalin versus gabapentin abuse-related events was 1.77.Conclusion: Though not traditionally thought of as drugs of abuse, over 600 cases of gabapentinoid abuse were reported in the time frame analyzed, prompting the need for further study and regulatory investigation.