Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA.
Center for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA.
Expert Rev Gastroenterol Hepatol. 2024 Jul;18(7):389-395. doi: 10.1080/17474124.2024.2380315. Epub 2024 Jul 15.
We aimed to examine the common adverse drug reactions (ADRs) of metoclopramide, FDA-approved for treating many gastrointestinal conditions including gastroparesis, and prucalopride, FDA-approved for treating chronic idiopathic constipation but used off-label for other gastrointestinal conditions including gastroparesis.
The FDA Adverse Event Reporting System (FAERS) was analyzed from January 2013 to December 2023. ADR reports regarding use of only metoclopramide or prucalopride were analyzed following exclusion of reports indicating use for treatment of non-gastrointestinal conditions.
Analysis of 1,085 reports on metoclopramide revealed tardive dyskinesia ( = 393, 36.2%) and dystonia ( = 170, 15.7%) among the most reported ADRs in addition to QTc prolongation ( = 16, 1.5%) with progression to Torsade de pointes ( = 5, 0.5%) and triggering of pheochromocytoma crisis ( = 24, 2.2%). Analysis of 865 reports on prucalopride revealed headache ( = 120, 13.9%), diarrhea ( = 116, 13.4%), and abdominal pain ( = 100, 11.6%) as the most common ADRs with 22 reports (2.5%) of dystonia with the use of prucalopride.
This FAERS database analysis shows post-marketing reports of ADRs from metoclopramide most frequently include tardive dyskinesia, dystonia, and tremor in addition to potentially fatal arrhythmias such as Torsade de pointes. Consumers of prucalopride may also be at risk of dystonia and other ADRs.
我们旨在研究胃动力药物——胃复安和治疗慢性特发性便秘的药物——普芦卡必利的常见不良反应（ADR）。胃复安已被 FDA 批准用于治疗多种胃肠道疾病，包括胃轻瘫；普芦卡必利则被 FDA 批准用于治疗慢性特发性便秘，但也被超适应证用于治疗包括胃轻瘫在内的其他胃肠道疾病。
从 2013 年 1 月至 2023 年 12 月，分析了 FDA 不良事件报告系统（FAERS）的数据。在排除了用于治疗非胃肠道疾病的报告后，对仅使用胃复安或普芦卡必利的不良反应报告进行了分析。
对 1085 例胃复安报告的分析显示，除 QTc 延长（16 例，1.5%）导致尖端扭转型室性心动过速（5 例，0.5%）和触发嗜铬细胞瘤危象（24 例，2.2%）外，最常报告的不良反应还包括迟发性运动障碍（393 例，36.2%）和肌张力障碍（170 例，15.7%）。对 865 例普芦卡必利报告的分析显示，最常见的不良反应是头痛（120 例，13.9%）、腹泻（116 例，13.4%）和腹痛（100 例，11.6%），使用普芦卡必利还会出现 22 例（2.5%）的肌张力障碍。
这项 FAERS 数据库分析显示，胃复安的上市后不良反应报告最常包括迟发性运动障碍、肌张力障碍和震颤，此外还可能出现尖端扭转型室性心动过速等致命性心律失常。普芦卡必利的使用者也可能存在肌张力障碍和其他不良反应的风险。
