Analysis of licorice‐induced pseudoaldosteronism in the Japanese Adverse Drug Event Report database. Issue 1 (2nd September 2015)

• Record Type: Journal Article
• Authors: Kato, Yamato; Umetsu, Ryogo; Hosoya, Naoki; Ueda, Natsumi; Abe, Junko; Nakayama, Yoko; Motooka, Yumi; Kinosada, Yasutomi; Oyama, Masayoshi; Nakamura, Mitsuhiro
• Is Part Of: Traditional & Kampo Medicine. Volume 3:Issue 1(2016)
• Page Start: 63
• Page End: 70
• Publication Date: 2015-09-02
• Subjects: adverse drug event -- JADER -- licorice -- pseudoaldosteronism; Medicine, Oriental -- Japan -- Periodicals; Medicine, Chinese -- Japan -- Periodicals; Medicine, East Asian Traditional; Japan; Medicine, Chinese; Medicine, Oriental; Japan; Electronic journals; Periodicals; Periodicals; 615
• DOI: 10.1002/tkm2.1029
• Languages: English
• ISSNs: 2053-4515

Abstract

ABSTRACT: Aim: We analyzed the association of age, sex, and dosage with licorice‐associated pseudoaldosteronism using spontaneous adverse event reports. Methods: Pseudoaldosteronism incidence data from 2004 to 2013 were obtained from the Japanese Adverse Drug Event Report (JADER) database. These reports were analyzed using a reporting odds ratio (ROR). Medical Dictionary for Regulatory Activities‐preferred terms were used to identify pseudoaldosteronism. Results: Pseudoaldosteronism was reported frequently in female patients aged >50 years. ROR of pseudoaldosteronism were calculated and stratified by licorice dosage. ROR (95%CI) for doses <2.5, 2.5–4.9, and ≥5.0 g were 20.9 (15.1–28.8), 26.1 (15.1–45.0), and 147.3 (150.3–206.0), respectively. Conclusion: Despite the limitations of spontaneous reporting, licorice dosage may be associated with pseudoaldosteronism. Considering the causality restraint of the current analysis, further epidemiological studies are recommended.