Title |
有害事象自発報告データベース(JADER)を用いた一般用医薬品の総合感冒剤による有害事象プロファイルの検討
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Published in |
Yakugaku Zasshi = Journal of Pharmaceutical Society of Japan, January 2018
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DOI | 10.1248/yakushi.17-00172 |
Pubmed ID | |
Authors |
Sayaka Sasaoka, Haruna Hatahira, Shiori Hasegawa, Yumi Motooka, Akiho Fukuda, Misa Naganuma, Ryogo Umetsu, Satoshi Nakao, Akari Shimauchi, Natsumi Ueda, Kouseki Hirade, Kazuhiro Iguchi, Mitsuhiro Nakamura |
Abstract |
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. |
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Geographical breakdown
Country | Count | As % |
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Unknown | 2 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 9 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Lecturer > Senior Lecturer | 1 | 11% |
Other | 1 | 11% |
Lecturer | 1 | 11% |
Student > Bachelor | 1 | 11% |
Professor | 1 | 11% |
Other | 3 | 33% |
Unknown | 1 | 11% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 3 | 33% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 22% |
Nursing and Health Professions | 1 | 11% |
Economics, Econometrics and Finance | 1 | 11% |
Engineering | 1 | 11% |
Other | 0 | 0% |
Unknown | 1 | 11% |