抗抑郁药广泛用于治疗抑郁症和其他精神疾病。先前的研究表明,肝毒性是与抗抑郁药相关的主要不良事件。因此,抗抑郁剂引起的药物性肝损伤(DILI)值得关注。
■调查美国食品和药物管理局不良事件报告系统(FAERS)数据库中由于使用抗抑郁药而报告的DILI不良事件。
■对自发报告的不良事件进行不相称性分析,以评估抗抑郁药与DILI之间的关联。
■FAERS2004年1月1日至2021年12月31日的数据是使用报告优势比(ROR)和信息成分(IC)进行汇编和分析的。
■根据FAERS数据库,在324,588例服用抗抑郁药的病例中,10355例被确定为DILI病例。在确定的42种抗抑郁药中,奈法唑酮(n=47,ROR=7.79,IC=2.91),氟伏沙明(n=29,ROR=4.69,IC=2.20),氯米帕明(n=24,ROR=3.97,IC=1.96)对胆汁淤积性损伤的ROR最高;米安色林(n=3,ROR=21.46,IC=3.99),奈法唑酮(n=264,ROR=18.67,IC=3.84),和马普替林(n=15,ROR=5.65,IC=2.39)用于肝细胞损伤;和奈法唑酮(n=187,ROR=12.71,IC=0.48),氯米帕明(n=35,ROR=2.07,IC=0.26),和米氮平(n=483,ROR=1.96,IC=0.94)用于严重的药物相关肝病。只有奈法唑酮引起肝功能衰竭信号(n=48,ROR=18.64,IC=4.16)。关于相对较新的抗抑郁药物的不良反应的报道有限,比如米纳西普兰,维洛嗪,艾氯胺酮,还有Tianeptine,和那些未经食品和药物管理局批准的,如瑞波西汀和阿戈美拉汀。
■在DILI和奈法唑酮之间观察到显著关联。度洛西汀和氯米帕明与三个DILI类别相关,除了肝衰竭.不相称性分析不能得出抗抑郁药和DILI之间明确的因果关系。需要进一步的研究来评估新一代抗抑郁药引起DILI的倾向。
抗抑郁药引起的药物性肝损伤的不良事件报告简介:不良药物事件(ADE)是指与药物相关的所有有害事件,包括药物不良反应(ADR)和其他意外事件。ADE涵盖的范围更广,对于药品上市后的监督非常重要。这项研究调查了与抗抑郁药物相关的药物性肝损伤(DILI)不良事件的自愿报告。方法:我们从美国食品和药物管理局不良事件报告系统(FAERS)数据库中检索了2004年至2021年之间提交的有关DILI和相关术语的数据。我们分析了与抗抑郁药相关的DILI信号检测数据。结果:我们检索并分析了324,588份抗抑郁药物报告。共有10,355份报告与DILI有关。每个DILI类别中报告比值比(ROR)最高的三种药物如下:胆汁淤积性损伤(奈法唑酮,氟伏沙明,和氯米帕明)肝细胞损伤(米安色林,奈法唑酮,和马普替林)肝功能衰竭(奈法唑酮)药物相关的肝病-严重事件(奈法唑酮,氯米帕明,和米氮平)某些药物没有信号的原因可能是:与药物在市场上的创新无关,未获得食品和药物管理局(FDA)的批准,由于其他原因,缺乏对不良事件的自愿报告。结论:利用公开的大型数据库进行的药物安全性研究可以评估临床实践中广泛使用的抗抑郁药的安全性。奈法唑酮,度洛西汀,氯米帕明与显著的DILI信号相关。需要进一步的研究来确定新一代抗抑郁药的安全性问题。
UNASSIGNED: Antidepressants are widely used to manage depression and other psychiatric diseases. A previous study revealed that hepatotoxicity was the main adverse event related to
antidepressants. Therefore, drug-induced liver injury (DILI) caused by
antidepressants deserves more attention.
UNASSIGNED: To investigate DILI adverse events reported due to antidepressant use in the United States Food and Drug Administration Adverse Events Reporting System (FAERS) database.
UNASSIGNED: A disproportionality analysis of spontaneously reported adverse events was conducted to assess the association between antidepressant drugs and DILI.
UNASSIGNED: FAERS data from 1 January 2004 to 31 December 2021 were compiled and analyzed using the reporting odds ratio (ROR) and information component (IC).
UNASSIGNED: As per the FAERS database, of the 324,588 cases that were administered antidepressants, 10,355 were identified as cases with DILI. Among the identified 42 antidepressants, nefazodone (n = 47, ROR = 7.79, IC = 2.91), fluvoxamine (n = 29, ROR = 4.69, IC = 2.20), and clomipramine (n = 24, ROR = 3.97, IC = 1.96) had the highest ROR for cholestatic injury; mianserin (n = 3, ROR = 21.46, IC = 3.99), nefazodone (n = 264, ROR = 18.67, IC = 3.84), and maprotiline (n = 15, ROR = 5.65, IC = 2.39) for hepatocellular injury; and nefazodone (n = 187, ROR = 12.71, IC = 0.48), clomipramine (n = 35, ROR = 2.07, IC = 0.26), and mirtazapine (n = 483, ROR = 1.96, IC = 0.94) for severe drug-related hepatic disorders. Only nefazodone elicited hepatic failure signals (n = 48, ROR = 18.64, IC = 4.16). There are limited reports on the adverse reactions of relatively new antidepressant drugs, such as milnacipran, viloxazine, esketamine, and tianeptine, and those not approved by the Food and Drugs Administration, such as reboxetine and agomelatine.
UNASSIGNED: A significant association was observed between DILI and nefazodone. Duloxetine and clomipramine were associated with three DILI categories, except hepatic failure. The disproportionality analysis cannot conclude on a definite causal link between antidepressants and DILI. Additional research is required to assess new-generation antidepressants for their propensity to cause DILI.
Adverse events reported on drug-induced liver injury caused by antidepressants Introduction: Adverse drug events (ADEs) refer to all harmful events related to medications, including adverse drug reactions (ADRs) and other unexpected events. ADEs encompass a wider range and are very important for the post-market surveillance of drugs. This study investigated the voluntary reporting of drug-induced liver injury (DILI) adverse events associated with antidepressant drugs. Methods: We retrieved data on DILI and related terms submitted between 2004 and 2021 from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) database. We analyzed the data for the detection of DILI signals associated with
antidepressants. Results: We retrieved and analyzed 324,588 reports on antidepressant drugs. A total of 10,355 reports were associated with DILI. The three drugs with the highest reporting odds ratio (ROR) in each DILI category were as follows: cholestatic injury (nefazodone, fluvoxamine, and clomipramine)hepatocellular injury (mianserin, nefazodone, and maprotiline)hepatic failure (nefazodone)drug related hepatic disorders-severe events (nefazodone, clomipramine, and mirtazapine) The absence of signals from some drugs may be due to: non-association with DILInovelty of the drug in the marketnon-approval from the Food and Drugs Administration (FDA)lack of voluntary reporting of adverse events due to other reasons Conclusion: Drug safety studies utilizing publicly available large databases allowed the evaluation of the safety profile of widely used antidepressant drugs in clinical practice. Nefazodone, duloxetine, and clomipramine were associated with significant DILI signals. Further research is needed to determine the safety concerns of new-generation
antidepressants.