Sasaoka Sayaka, Hatahira Haruna, Hasegawa Shiori, Motooka Yumi, Fukuda Akiho, Naganuma Misa, Umetsu Ryogo, Nakao Satoshi, Shimauchi Akari, Ueda Natsumi, Hirade Kouseki, Iguchi Kazuhiro, Nakamura Mitsuhiro
Laboratory of Drug Informatics, Gifu Pharmaceutical University.
Laboratory of Community Pharmacy, Gifu Pharmaceutical University.
Yakugaku Zasshi. 2018;138(1):123-134. doi: 10.1248/yakushi.17-00172.
OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for "skin and subcutaneous tissue disorders", "hepatobiliary disorders", and "immune system disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for "hepatobiliary disorders" than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.
非处方复方感冒疗法在日本被广泛使用。在本研究中，我们旨在基于成分，利用日本药品不良事件报告（JADER）数据库评估非处方复方感冒疗法的不良事件情况。JADER数据库包含了2004年4月至2016年11月期间的430587份报告。报告了1084例与使用非处方复方感冒疗法相关的不良事件。采用报告比值比（ROR）来检测安全信号。根据《药物监管活动医学词典》（MedDRA）的系统器官分类，“皮肤和皮下组织疾病”“肝胆疾病”以及“免疫系统疾病”的ROR值分别为9.82（8.71 - 11.06）、2.63（2.25 - 3.07）和3.13（2.63 - 3.74）。含对乙酰氨基酚的非处方复方感冒疗法的“肝胆疾病”报告率显著高于不含对乙酰氨基酚的非处方复方感冒疗法。我们在实际应用中证明了非处方复方感冒疗法存在潜在风险。我们的结果表明，对使用非处方复方感冒疗法的个体进行监测很重要。
