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

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.

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Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database

SAGE Open Medicine ◽

10.1177/2050312118772475 ◽

2018 ◽

Vol 6 ◽

pp. 205031211877247 ◽

Cited By ~ 4

Author(s):

Misa Naganuma ◽

Yumi Motooka ◽

Sayaka Sasaoka ◽

Haruna Hatahira ◽

Shiori Hasegawa ◽

...

Keyword(s):

Adverse Events ◽

Renal Impairment ◽

Confidence Interval ◽

Adverse Drug Event ◽

Association Rule ◽

Drug Event ◽

Reporting Odds Ratio ◽

Platinum Compounds ◽

Event Report ◽

Rule Mining

Objectives: Platinum compounds cause several adverse events, such as nephrotoxicity, gastrointestinal toxicity, myelosuppression, ototoxicity, and neurotoxicity. We evaluated the incidence of renal impairment as adverse events are related to the administration of platinum compounds using the Japanese Adverse Drug Event Report database. Methods: We analyzed adverse events associated with the use of platinum compounds reported from April 2004 to November 2016. The reporting odds ratio at 95% confidence interval was used to detect the signal for each renal impairment incidence. We evaluated the time-to-onset profile of renal impairment and assessed the hazard type using Weibull shape parameter and used the applied association rule mining technique to discover undetected relationships such as possible risk factor. Results: In total, 430,587 reports in the Japanese Adverse Drug Event Report database were analyzed. The reporting odds ratios (95% confidence interval) for renal impairment resulting from the use of cisplatin, oxaliplatin, carboplatin, and nedaplatin were 2.7 (2.5–3.0), 0.6 (0.5–0.7), 0.8 (0.7–1.0), and 1.3 (0.8–2.1), respectively. The lower limit of the reporting odds ratio (95% confidence interval) for cisplatin was >1. The median (lower–upper quartile) onset time of renal impairment following the use of platinum-based compounds was 6.0–8.0 days. The Weibull shape parameter β and 95% confidence interval upper limit of oxaliplatin were <1. In the association rule mining, the score of lift for patients who were treated with cisplatin and co-administered furosemide, loxoprofen, or pemetrexed was high. Similarly, the scores for patients with hypertension or diabetes mellitus were high. Conclusion: Our findings suggest a potential risk of renal impairment during cisplatin use in real-world setting. The present findings demonstrate that the incidence of renal impairment following cisplatin use should be closely monitored when patients are hypertensive or diabetic, or when they are co-administered furosemide, loxoprofen, or pemetrexed. In addition, healthcare professionals should closely assess a patient’s background prior to treatment.

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Precautions for Use of the Japanese Adverse Drug Event Report Database and Factors Affecting the Number of Adverse Events

Japanese Journal of Biometrics ◽

10.5691/jjb.37.89 ◽

2016 ◽

Vol 37 (2) ◽

pp. 89-100 ◽

Cited By ~ 2

Author(s):

Hidetaka Sekiyama ◽

Takashi Sozu

Keyword(s):

Adverse Events ◽

Adverse Drug Event ◽

Drug Event ◽

Event Report ◽

Factors Affecting

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Analysis of Adverse Events Associated with the Anti-Allergic Agents Rx-to-OTC-Switched Using Data Mining of the Japanese Adverse Drug Event Report (JADER) Database

Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) ◽

10.5649/jjphcs.41.667 ◽

2015 ◽

Vol 41 (9) ◽

pp. 667-675 ◽

Cited By ~ 2

Author(s):

Yoshihiro Noguchi ◽

Hiroki Esaki ◽

Shoko Asano ◽

Takafumi Yokoi ◽

Kazumasa Usui ◽

...

Keyword(s):

Data Mining ◽

Adverse Events ◽

Adverse Drug Event ◽

Drug Event ◽

Event Report ◽

Using Data

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Evaluation of pregabalin-induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases

Journal of Clinical Pharmacy and Therapeutics ◽

10.1111/jcpt.12790 ◽

2018 ◽

Vol 44 (2) ◽

pp. 285-291 ◽

Cited By ~ 3

Author(s):

Ririka Mukai ◽

Shiori Hasegawa ◽

Ryogo Umetsu ◽

Satoshi Nakao ◽

Kazuyo Shimada ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Adverse Drug Event ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Drug Event ◽

Event Report ◽

Event Reporting

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Disproportionality Analysis of Safety Signals for a Wide Variety of Opioid-Related Adverse Events in Elderly Patients Using the Japanese Adverse Drug Event Report (JADER) Database

Biological and Pharmaceutical Bulletin ◽

10.1248/bpb.b20-00904 ◽

2021 ◽

Vol 44 (5) ◽

pp. 627-634

Author(s):

Takashi Omoto ◽

Junichi Asaka ◽

Takamasa Sakai ◽

Fumihiko Sato ◽

Nobuyuki Goto ◽

...

Keyword(s):

Adverse Events ◽

Elderly Patients ◽

Adverse Drug Event ◽

Drug Event ◽

Event Report ◽

Disproportionality Analysis ◽

Safety Signals

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Analyses of non-benzodiazepine-induced adverse events and prognosis in elderly patients based on the Japanese adverse drug event report database

Journal of Pharmaceutical Health Care and Sciences ◽

10.1186/s40780-018-0106-2 ◽

2018 ◽

Vol 4 (1) ◽

Cited By ~ 3

Author(s):

Yoshihiro Noguchi ◽

Anri Ueno ◽

Hayato Katsuno ◽

Manami Otsubo ◽

Aki Yoshida ◽

...

Keyword(s):

Adverse Events ◽

Elderly Patients ◽

Adverse Drug Event ◽

Drug Event ◽

Event Report

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Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

Vaccines ◽

10.3390/vaccines8030357 ◽

2020 ◽

Vol 8 (3) ◽

pp. 357

Author(s):

Aoi Noda ◽

Takamasa Sakai ◽

Masami Tsuchiya ◽

Gen Oyanagi ◽

Taku Obara ◽

...

Keyword(s):

Human Papillomavirus ◽

Adverse Events ◽

Adverse Drug Event ◽

Haemophilus Influenzae Type ◽

Drug Event ◽

Loss Of Consciousness ◽

Haemophilus Influenzae Type B ◽

Type B ◽

Event Report ◽

Pharmacovigilance Activity

The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10–19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of “death” and “did not recover” as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10–19 years, respectively. The most frequently reported vaccine–reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10–19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

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