Analysis of patients with hypomagnesemia using the Japanese Adverse Drug Event Report database (JADER)

Hiroyuki Tanaka1, Yuka Yoshiba1, Tomoko Watanabe1, Mitsutoshi Satoh2, Toshihiro Ishii1

1Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba 274-8510, Japan.
2Department of Toxicology and Pharmacology, Division of Pharmacy Practice, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, Japan

Abstract


Summary – Purpose. In order to clarify the occurrence of hypomagnesemia in Japan, we conducted a database search and analysis using the Japanese Adverse Drug Event Report database (JADER). Methods. Among the cases recorded in JADER between April 2004 and December 2015, we targeted “hypomagnesemia” and analyzed the patients’ backgrounds, drug involvement, other adverse events reported with hypomagnesemia, the time of hypomagnesemia onset, outcomes, and year when reported. For drugs with three or more reports, the signal index was calculated using the Reporting Odds Ratio (ROR) method. In addition, the association between hypomagnesemia onset and other adverse events was investigated using association analysis. Results. The total number of reported hypomagnesemia cases was 201. Males accounted for 62.7%, and patients in their sixties formed a large peak. Three or more cases were reported for 23 causative drugs, among which anti-EGFR antibody, calcineurin inhibitor, platinum antitumor agent and proton pump inhibitor accounted for the majority. ROR analysis detected signals for 18 drugs, and an association was found between hypomagnesemia and other electrolyte abnormalities for those drugs. The median time until onset of hypomagnesemia was classified into three patterns: around 10 days, around 30 days, and longer. Analysis of the report year revealed an increasing tendency in recent years, although increases/decreases were evident depending on fiscal years. Conclusion. Our survey was able to reveal the factors associated with the occurrence of hypomagnesemia.

J Pharm Pharm Sci, 21 (0): 46-53, 2018

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DOI: http://dx.doi.org/10.18433/jpps29692