Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting Database

A, Ichida; Motohashi, Hideyuki; Kitano, Asuka; Takayama, Ayami; Inui, Ken Ichi; Yano, Yoshitaka

doi:10.1177/2168479015618694

Cited by 1 publication

(1 citation statement)

References 22 publications

(30 reference statements)

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“…In this study, adverse events related to Yokukansan were extracted from the JADAR database using methods similar to those used in our previous studies [11,12]. The database was queried using the keyword "Yokukansan" as a primary suspected drug (http://info.pmda.go.jp).…”

Section: Analyses Of the Profiles Of Patients Suffering From Adverse mentioning

confidence: 99%

Hypokalemia and Related Symptoms by Yokukansan in Patients with Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Study of Elderly Inpatients

Takeuchi¹,

Shintani²

2016

Adv Pharmacoepidemiol Drug Saf

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Yokukansan is a Japanese traditional medicine that has been used for behavioral and psychological symptoms of dementia. Although the efficacy of Yokukansan have been reported, few studies have focused on its adverse effects. In this study, the adverse effects in hospitalized patients treated with Yokukansan were evaluated retrospectively and compared with those listed in the Japanese Adverse Drug Event Report database from the Pharmaceutical and Medical Device Agency. A total of 21 patients who were prescribed Yokukansan at Rakuwakai Otowa Hospital from April 2013 to September 2013 were registered as subjects for this study. Patient profiles, such as age, gender, serum potassium levels, AST and ALT, were evaluated. Serum potassium levels decreased significantly from 4.3 ± 0.6 mEq/L to 3.6 ± 0.4 mEq/L after treatment with Yokukansan, and 61.9% of the patients demonstrated hypokalemia. In addition, the pre-treatment serum potassium levels were associated with the induction of hypokalemia by Yokukansan. The onset date of hypokalemia was varied from 2 to 1,154 days in Otowa data and from 2 to 1,533 days in JADER data. In terms of the number of days to the onset of hypokalemia, there was no significant difference between the Rakuwakai Otowa Hospital and results of Japanese Adverse Drug Event Report database. It is necessary to pay attention to patients during the treatment with Yokukansan, even if treatment period was long term.

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Section: Analyses Of the Profiles Of Patients Suffering From Adverse mentioning

confidence: 99%

Hypokalemia and Related Symptoms by Yokukansan in Patients with Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Study of Elderly Inpatients

Takeuchi¹,

Shintani²

2016

Adv Pharmacoepidemiol Drug Saf

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show abstract

Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting Database

Cited by 1 publication

References 22 publications

Hypokalemia and Related Symptoms by Yokukansan in Patients with Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Study of Elderly Inpatients

Hypokalemia and Related Symptoms by Yokukansan in Patients with Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Study of Elderly Inpatients

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