Department of Clinical Research, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India.
Department of Pharmacology, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India.
Acta Neurol Scand. 2022 Nov;146(5):623-627. doi: 10.1111/ane.13690. Epub 2022 Aug 27.
Clobazam is a well-known benzodiazepine used as an anti-anxiety drug as well as an anti-epileptic, particularly for patients who are not responding to first-line treatments. Recent case reports have indicated the association of clobazam with drug reaction with eosinophilia systemic symptoms syndrome (DRESS Syndrome). However, DRESS syndrome is not known to be associated with clobazam. Thus, the main objective of the current study was to identify the potential signal of clobazam-associated DRESS Syndrome.
MATERIALS & METHODS: US FDA Adverse event reporting system (US FAERS), pharmacovigilance data 2004Q1-2021Q3 was extracted using OpenVigil 2.1-MedDRA-v24. The Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR) with a Chi-Square value (95% confidence interval), and number of cases (≥3) were used as disproportionality analysis parameters.
A total of 141 drug-event combinations were reported and results of disproportionality analysis indicate the positive signal of DRESS syndrome with clobazam. The signal strength was decreased after removing the cases of concomitantly administered drugs (phenytoin, levetiracetam, and valproic acid); however, the association of clobazam with DRESS syndrome remains statistically significant. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the male and female groups is almost similar.
The DRESS syndrome is identified as a novel signal with clobazam. However, further causality assessment is required.
氯巴占是一种广为人知的苯二氮䓬类药物，可用作抗焦虑药物和抗癫痫药物，尤其适用于对一线治疗无反应的患者。最近的病例报告表明，氯巴占与药物反应伴嗜酸性粒细胞增多和全身症状（DRESS 综合征）有关。然而，目前并不认为 DRESS 综合征与氯巴占有关。因此，本研究的主要目的是确定氯巴占相关 DRESS 综合征的潜在信号。
使用 OpenVigil 2.1-MedDRA-v24 从美国食品药品监督管理局不良事件报告系统（US FAERS）中提取 2004Q1-2021Q3 的药物警戒数据。比例报告比值（PRR）、卡方值（95%置信区间）的报告比值比（ROR）和病例数（≥3）被用作不成比例分析参数。
共报告了 141 种药物-事件组合，不成比例分析结果表明氯巴占与 DRESS 综合征存在阳性信号。在去除同时使用的药物（苯妥英、左乙拉西坦和丙戊酸）的病例后，信号强度降低，但氯巴占与 DRESS 综合征的关联仍然具有统计学意义。亚组分析结果表明，18-64 岁年龄组的病例数多于其他年龄组，而男性和女性组的病例数几乎相似。
DRESS 综合征被确定为氯巴占的一个新信号。然而，需要进一步进行因果关系评估。
